Surgipro
Monofilament Polypropylene,KV-7,D/A,1x Blue Strand with Firm PTFE Pledget 7x3x1.5mm
3manufacturers in China registered for this device type
133catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| 510(k) | K954808 |
| Record published | 2015-09-01 |
| Record revised | 2025-06-24 (version 16) |
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 | Handling environment temperature up to 130 °F |
| Packaging | Case of 36, case of 12, case of 24, pack_or_inner_pack of 12 |
| Sizes | Length 2 to 96 in |
| Distribution end date | 2025-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP-434 | Diameter,0,N/A; | In distribution |
| XX-5263 | diameter,2/0,N/A; | In distribution |
| VP-736-M | Diameter,7/0,N/A; | In distribution |
| 3-CP-360 | Length 24 in | In distribution |
| SP-649 | diameter,3/0,N/A; | In distribution |
| XX2219 | Length 30 in | In distribution |
| CP-435 | Diameter,1,N/A; | In distribution |
| CP41G | Diameter, 1, N/A; | In distribution |
| CP-415 | Diameter,1,N/A; | In distribution |
| SP-690 | diameter,0,N/A; | In distribution |
| VP-945 | Diameter,2/0,N/A; | In distribution |
| VP-965 | Diameter,4/0,N/A; | In distribution |
| CP-425 | Diameter,1,N/A; | In distribution |
| SP-868G | diameter,2/0,N/A; | In distribution |
| SP-685 | diameter,2/0,N/A; | In distribution |
| SP-683 | diameter,4/0,N/A; | In distribution |
| SP-665G | diameter,3/0,N/A; | In distribution |
| X-1209 | diameter,2/0,N/A; | In distribution |
| CP-824 | Diameter,1,N/A; | In distribution |
| XX-5209 | Length 48 in | In distribution |
| VP-628 | diameter,7/0,N/A; | In distribution |
| VP-937 | Diameter,2/0,N/A; | In distribution |
| SP-622-BC | diameter,3/0,N/A; | In distribution |
| VP-833 | Diameter,2/0,N/A; | In distribution |
| VP-853 | Diameter,2/0,N/A; | In distribution |
| P-2790G | Diameter,10/0,N/A; | In distribution |
| CP-412 | Length 30 in | In distribution |
| SP-661 | diameter,5/0,N/A; | In distribution |
| SP-1644 | Diameter,4/0,N/A; | In distribution |
| SP-660 | diameter,6/0,N/A; | In distribution |
| SP-868 | diameter,2/0,N/A; | In distribution |
| CP-423 | Diameter,2/0,N/A; | In distribution |
| VP-843 | Diameter,2/0,N/A; | In distribution |
| SP-670 | diameter,4/0,N/A; | In distribution |
| SP-1606 | Length 18 in | In distribution |
| SP-660G | diameter,6/0,N/A; | In distribution |
| SP-629 | diameter,4/0,N/A; | In distribution |
| CP-834-L | Diameter,1,N/A; | In distribution |
| SP-1696 | Length 18 in | In distribution |
| CP-16-M | Diameter,2/0,N/A; | In distribution |
| VP-956 | Diameter,3/0,N/A; | In distribution |
| CP-424 | Diameter,0,N/A; | In distribution |
| VP-523 | diameter,2/0,N/A; | In distribution |
| CP-92-M | Diameter,0,N/A; | In distribution |
| SP-1647G | Length 18 in | In distribution |
| SP-675 | diameter,3/0,N/A; | In distribution |
| SP-623-BC | diameter,2/0,N/A; | In distribution |
| SP-661G | diameter,5/0,N/A; | In distribution |
| SP-1617 | Length 18 in | In distribution |
| VP-834 | Diameter,0,N/A; | In distribution |
| CP-17-M | Diameter,0,N/A; | In distribution |
| CP-825 | Diameter,2,N/A; | In distribution |
| CP-535 | Diameter,1,N/A; | In distribution |
| SP-665 | diameter,3/0,N/A; | In distribution |
| VP-533 | diameter,2/0,N/A; | In distribution |
| CP-836 | Diameter,1,N/A; | In distribution |
| VP-151 | diameter,2/0,N/A; | In distribution |
| CP-453 | Length 30 in | In distribution |
| SP-2698G | diameter,5/0,N/A; | In distribution |
| SP-631 | diameter,4/0,N/A; | In distribution |
| CP-30-M | Diameter,0,N/A; | In distribution |
| SP-684G | diameter,3/0,N/A; | In distribution |
| VP-891 | Diameter,4/0,N/A; | In distribution |
| VP-977 | Diameter,2/0,N/A; | In distribution |
| SP-1618 | Length 18 in | In distribution |
| XX-5000 | Length 48 in | In distribution |
| SP-623 | diameter,2/0,N/A; | In distribution |
| SP622G | diameter,3/0,N/A; | In distribution |
| X1374 | Length 48 in | In distribution |
| SP-5687 | diameter,3/0,N/A; | In distribution |
| SP690G | diameter,0,N/A; | In distribution |
| CP-845 | Diameter,1,N/A; | In distribution |
| VPF-543 | Diameter,2/0,N/A; | In distribution |
| CP-460 | Diameter,2,N/A; | In distribution |
| VP-978 | Diameter,0,N/A; | In distribution |
| X-1280 | Diameter,1,N/A; | In distribution |
| SP-684 | diameter,3/0,N/A; | In distribution |
| CP-844 | Length 30 in | In distribution |
| CP-10-M | Diameter,0,N/A; | In distribution |
| CP42G | Diameter, 3/0, N/A; | In distribution |
| SP-621 | diameter,4/0,N/A; | In distribution |
| SP-1636 | Diameter,6/0,N/A; | In distribution |
| SP-1693G | diameter,3/0,N/A; | In distribution |
| XX-5246 | Length 36 in | In distribution |
| P-2756K | diameter,10/0,N/A; | In distribution |
| CP-414 | Diameter,0,N/A; | In distribution |
| SP-1634 | Length 18 in | In distribution |
| CP-824-L | Diameter,1,N/A; | In distribution |
| SP-683G | diameter,4/0,N/A; | In distribution |
| CP-454 | Diameter,0,N/A; | In distribution |
| SP-689 | diameter,2/0,N/A; | In distribution |
| P-2771K | Diameter,10/0,N/A; | In distribution |
| SP-1643 | Diameter,3/0,N/A; | In distribution |
| CP-455 | Diameter,1,N/A; | In distribution |
| GP-282 | Diameter,2/0,N/A; | In distribution |
| SP-1635 | Diameter,5/0,N/A; | In distribution |
| CP-433 | Diameter,2/0,N/A; | In distribution |
| SP-1696G | diameter,7/0,N/A; | In distribution |
| CP-411 | Length 30 in | In distribution |
| SP-1697 | diameter,6/0,N/A; | In distribution |
| CP-422 | Diameter,3/0,N/A; | In distribution |
| CP-443 | Diameter,2/0,N/A; | In distribution |
| SP-622 | diameter,3/0,N/A; | In distribution |
| VP-543 | Length 48 in | In distribution |
| SP-559G | Length 18 in | In distribution |
| VP-897-M | Length 30 in | Withdrawn |
| P-2794G | Diameter,10/0,N/A; | Withdrawn |
| SP-1664G | Diameter,4/0,N/A; | Withdrawn |
| P-2795G | Diameter,10/0,N/A; | Withdrawn |
| XX-5261 | diameter,2/0,N/A; | Withdrawn |
| X-1041 | Length 60 in | Withdrawn |
| X-1051 | diameter,0,N/A; | Withdrawn |
| XX-5050 | Diameter,2/0,N/A; | Withdrawn |
| X-1102 | diameter,0,N/A; | Withdrawn |
| VP-152 | diameter,2/0,N/A; | Withdrawn |
| XX-5072-L | Length 96 in | Withdrawn |
| CP45G | Length 30 in | Withdrawn |
| X-1236 | Length 18 in | Withdrawn |
| CP-957 | Length 30 in | Withdrawn |
| X-1303 | Diameter,2/0,N/A; | Withdrawn |
| CP-823 | Diameter,0,N/A; | Withdrawn |
| CP-9-M | Diameter,2/0,N/A; | Withdrawn |
| SP-3655 | diameter,5/0,N/A; | Withdrawn |
| CP-90-M | Diameter,0,N/A; | Withdrawn |
| VP-5261 | diameter,2/0,N/A; | Withdrawn |
| X-1253 | diameter,1,N/A; | Withdrawn |
| VP-987-X | Length 36 in | Withdrawn |
| X-1052 | diameter,0,N/A; | Withdrawn |
| 3CP-444 | Length 24 in | Withdrawn |
| X-1002 | Length 36 in | Withdrawn |
| XX-5069 | Diameter,5/0,N/A; | Withdrawn |
| XX-5238 | Length 60 in | Withdrawn |
| VP897M-2 | Length 30 in | Withdrawn |
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 |
| Prolene | Ethicon, Inc. | 765 |
| 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 |
| 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
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2026-06-24 | Class II | Equipment maintenance | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | 135,875 total |
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 8604 units |
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.