Prolene
PROLENE (Polypropylene) Suture Blue Monofilament, Hemo-Seal Needle Suture, Sterile, nonabsorbable surgical suture
3manufacturers in China registered for this device type
765catalogue numbers in this listing
4510(k) clearances naming this product code
22recalls on this code
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K133356 |
| Record published | 2015-09-01 |
| Record revised | 2026-01-06 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Box of 36, box of 12, box of 6, box of 24 |
| Distribution end date | 2018-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8455H | In distribution | |
| HS6857H | In distribution | |
| 8534H | In distribution | |
| M8301 | In distribution | |
| D10172 | In distribution | |
| M8707 | In distribution | |
| D7808 | In distribution | |
| EH7480H | In distribution | |
| D8229 | In distribution | |
| D9691 | In distribution | |
| W8304G | In distribution | |
| P8522 | In distribution | |
| D7172 | In distribution | |
| DC373 | In distribution | |
| D9860 | In distribution | |
| W8665 | In distribution | |
| D5498 | In distribution | |
| W8662 | In distribution | |
| EPM8734 | In distribution | |
| D10119 | In distribution | |
| D9677 | In distribution | |
| D6993 | In distribution | |
| EPM8701 | In distribution | |
| EH7555H | In distribution | |
| M8768 | In distribution | |
| EPM8205 | In distribution | |
| D8791 | In distribution | |
| D6212 | In distribution | |
| D7400 | In distribution | |
| 8623H | In distribution | |
| EPM8706 | In distribution | |
| W8803 | In distribution | |
| EPM8807 | In distribution | |
| PB20H | In distribution | |
| W753G | In distribution | |
| DC631 | In distribution | |
| W8664 | In distribution | |
| D6679 | In distribution | |
| EPM8733 | In distribution | |
| M8356 | In distribution | |
| EPM8805 | In distribution | |
| EPM8705 | In distribution | |
| D6010 | In distribution | |
| DC307 | In distribution | |
| 8410H | In distribution | |
| 8975H | In distribution | |
| F2828H | In distribution | |
| EP8734H | In distribution | |
| C821G | In distribution | |
| 8695G | In distribution | |
| W8101 | In distribution | |
| D8215 | In distribution | |
| EPM8732 | In distribution | |
| D10107 | In distribution | |
| 8964H | In distribution | |
| EPM8747 | In distribution | |
| D7143 | In distribution | |
| D8185 | In distribution | |
| D9994 | In distribution | |
| EP8805H | In distribution | |
| 8433H | In distribution | |
| D7689 | In distribution | |
| EP8806H | In distribution | |
| M8711 | In distribution | |
| D10104 | In distribution | |
| 8943H | In distribution | |
| 8767 | In distribution | |
| D8651 | In distribution | |
| D7843 | In distribution | |
| D7938 | In distribution | |
| D4624 | In distribution | |
| D7049 | In distribution | |
| 8740H | In distribution | |
| F2815H | In distribution | |
| 8717H | In distribution | |
| 8762H | In distribution | |
| EP8753H | In distribution | |
| EPM8751 | In distribution | |
| 9702H | In distribution | |
| 8962H | In distribution | |
| EH7583H | In distribution | |
| D8911 | In distribution | |
| EPM8768 | In distribution | |
| 8935H | In distribution | |
| D4085 | In distribution | |
| 8734H | In distribution | |
| D8282 | In distribution | |
| D9216 | In distribution | |
| EP8767LG | In distribution | |
| EH7222H | In distribution | |
| M8776 | In distribution | |
| EP8707H | In distribution | |
| M8805 | In distribution | |
| W8712 | In distribution | |
| 8714H | In distribution | |
| D9776 | In distribution | |
| D9602 | In distribution | |
| F2847H | In distribution | |
| DC284 | In distribution | |
| 8952H | In distribution | |
| D7684 | In distribution | |
| DC382 | In distribution | |
| M8743 | In distribution | |
| 8697G | In distribution | |
| D7103 | In distribution | |
| 8747H | In distribution | |
| EH7759H | In distribution | |
| D8231 | In distribution | |
| W8770G | In distribution | |
| M8720 | In distribution | |
| D9766 | In distribution | |
| W2790 | In distribution | |
| F2860H | In distribution | |
| 8711H | In distribution | |
| M8325 | In distribution | |
| M8706 | In distribution | |
| EPM8806 | In distribution | |
| M8318 | In distribution | |
| D8887 | In distribution | |
| M8321 | In distribution | |
| D9469 | In distribution | |
| 8934H | In distribution | |
| D9844 | In distribution | |
| 8757H | In distribution | |
| M8557 | In distribution | |
| 8417H | In distribution | |
| 9706H | In distribution | |
| EPM8776 | In distribution | |
| W8571 | In distribution | |
| EPM8704 | In distribution | |
| 8776H | In distribution | |
| 8860H | In distribution | |
| EH7242H | In distribution | |
| M8303 | In distribution | |
| D9835 | In distribution | |
| M8755 | In distribution | |
| M8730 | In distribution | |
| D9993 | In distribution | |
| 8709H | In distribution | |
| 8871H | In distribution | |
| EPM8738 | In distribution | |
| D5988 | In distribution | |
| 8318H | In distribution | |
| 1755G | In distribution | |
| D9658 | In distribution | |
| M8600 | In distribution | |
| 8834H | In distribution | |
| EPH7477H | In distribution | |
| EP8746H | In distribution | |
| D8581 | In distribution | |
| D10126 | In distribution | |
| EH7240H | In distribution | |
| M8725 | In distribution | |
| 8754H | In distribution | |
| EPH9702H | In distribution | |
| D3987 | In distribution | |
| D9425 | In distribution | |
| D7540 | In distribution | |
| D9364 | In distribution | |
| 8725H | In distribution | |
| W8718G | In distribution | |
| D9668 | In distribution | |
| D10130 | In distribution | |
| EP8704SLH | In distribution | |
| M8753 | In distribution | |
| D9068 | In distribution | |
| EP8705H | In distribution | |
| D7879 | In distribution | |
| M8307 | In distribution | |
| W2780 | In distribution | |
| 1757G | In distribution | |
| M8734 | In distribution | |
| 8704H | In distribution | |
| W8307G | In distribution | |
| W8121 | In distribution | |
| D9980 | In distribution | |
| W8813 | In distribution | |
| D8213 | In distribution | |
| 8521H | In distribution | |
| 8718H | In distribution | |
| D10139 | In distribution | |
| 8411H | In distribution | |
| EPM8800 | In distribution | |
| W8845 | In distribution | |
| EPH8725H | In distribution | |
| D4690 | In distribution | |
| 8630G | In distribution | |
| D8905 | In distribution | |
| D9421 | In distribution | |
| PK5676H | In distribution | |
| 8696G | In distribution | |
| D9066 | In distribution | |
| EPH8710H | In distribution | |
| 8528H | In distribution | |
| F1801H | In distribution | |
| 8434H | In distribution | |
| DC465 | In distribution | |
| EPM8755 | In distribution | |
| OSM8738 | In distribution | |
| D9746 | In distribution | |
| 8978H | In distribution | |
| EPM8726 | In distribution | |
| EPM8812SL | In distribution | |
| EP8752H | In distribution | |
| W8684G | In distribution | |
| W8702 | In distribution | |
| 8684G | In distribution | |
| D9150 | In distribution | |
| D6759 | In distribution | |
| W8807 | In distribution | |
| D7377 | In distribution | |
| D9434 | In distribution | |
| D6873 | In distribution | |
| D8413 | In distribution | |
| D6929 | In distribution | |
| M8305 | In distribution | |
| D7181 | In distribution | |
| D9566 | In distribution | |
| D9722 | In distribution | |
| W8400 | In distribution | |
| EH7167SLH | In distribution | |
| 8683G | In distribution | |
| D6909 | In distribution | |
| EH7568H | In distribution | |
| EPM8704SL | In distribution | |
| W8689 | In distribution | |
| M8764 | In distribution | |
| 8687H | In distribution | |
| M8738 | In distribution | |
| 8666H | In distribution | |
| EP8730H | In distribution | |
| EH7238H | In distribution | |
| D7530 | In distribution | |
| 8698G | In distribution | |
| D6175 | In distribution | |
| OSM8743 | In distribution | |
| F2832H | In distribution | |
| 8752H | In distribution | |
| D6781 | In distribution | |
| 8681G | In distribution | |
| 8806H | In distribution | |
| D3986 | In distribution | |
| 8444H | In distribution | |
| D9560 | In distribution | |
| EPM8660 | In distribution | |
| 8556G | In distribution | |
| C822G | In distribution | |
| 8951H | In distribution | |
| M8702 | In distribution | |
| D6038 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| Premilene | B Braun Surgical SA | 1,247 |
| Optilene | B Braun Surgical SA | 1,110 |
| Deknatel | Teleflex Medical LLC | 373 |
| Corolene® | Peters Surgical | 354 |
| WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 346 |
| Surgipro II | Covidien LP | 254 |
| Surgipro ll | Covidien LP | 152 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 140 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
| Gore-TEX Suture | W. L. Gore & Associates, Inc. | 113 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253572 | 2026-03-27 |
| K133356 | 2013-12-06 |
| K001625 | 2000-07-10 |
| K920437 | 1992-07-30 |
Recalls Naming This Product
22 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon Endo-Surgery, Inc. | UDI-DI | 2025-03-07 | Class II | Process control | Identified curing issues with the silicone during the needles manufacturing process. | 37,080 units | |
| Ethicon, Inc. | 510(k) number | 2024-12-20 | Class II | Process control | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. | 15,948 | |
| Ethicon, Inc. | 510(k) number | 2024-12-20 | Class II | Process control | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. | 78792 | |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 1752 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 1728 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 4452 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 3024 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 2844 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 15180 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 588 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 432 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 300 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 552 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 456 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 1020 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 48 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 4440 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 4968 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 276 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 372 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 144 | 2020-06-08 |
| Ethicon, Inc. | 510(k) number | 2018-05-07 | Class II | Package design/selection | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling | 516 | 2020-06-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-20 | Class II | Process control | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. | 48 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P890002 | 1989-05-31 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories, Inc. |
| P820083 | 1986-08-05 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.