Gore-TEX Suture
GORE-TEX SUTURE CHORDAE TENDIN CV-5 91cm DoubleArm TH-22-1dz
3manufacturers in China registered for this device type
113catalogue 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 | W. L. Gore & Associates, Inc., United States |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | P820083 |
| Record published | 2017-02-13 |
| Record revised | 2025-02-07 (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, manufacturing date |
| Packaging | Pack of 12, pack of 36 |
| Sizes | Length 46 to 122 cm |
| Distribution end date | 2026-03-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6M04 | Length 76 cm | In distribution |
| 5M16 | Length 76 cm | In distribution |
| 5N14 | Length 91 cm | In distribution |
| 5N08 | Length 91 cm | In distribution |
| 6J04 | Length 46 cm | In distribution |
| 8K08 | Length 61 cm | In distribution |
| 5K11 | Length 61 cm | In distribution |
| 6M10 | Length 76 cm | In distribution |
| 6K06 | Length 61 cm | In distribution |
| 3N10 | Length 91 cm | In distribution |
| 7M10 | Length 76 cm | In distribution |
| 2N02 | Length 91 cm | In distribution |
| 8K02 | Length 61 cm | In distribution |
| 5N10 | Length 91 cm | In distribution |
| 2N07 | Length 91 cm | In distribution |
| 2N01 | Length 91 cm | In distribution |
| 5K08 | Length 61 cm | In distribution |
| 5K02 | Length 61 cm | In distribution |
| 6J02 | Length 46 cm | In distribution |
| 2N08 | Length 91 cm | In distribution |
| 7J10 | Length 46 cm | In distribution |
| 2U22 | Length 122 cm | In distribution |
| 4U16 | Length 122 cm | In distribution |
| 6M12 | Length 76 cm | In distribution |
| 7M06 | Length 76 cm | In distribution |
| 3U20 | Length 122 cm | In distribution |
| 4N16 | Length 91 cm | In distribution |
| 5N02 | Length 91 cm | In distribution |
| 6K12 | Length 61 cm | In distribution |
| 7J02 | Length 46 cm | In distribution |
| 8M04 | Length 76 cm | In distribution |
| 2U05 | Length 122 cm | In distribution |
| 3N12 | Length 91 cm | In distribution |
| 0N07 | Length 91 cm | In distribution |
| 6M06 | Length 76 cm | In distribution |
| 6K02 | Length 61 cm | In distribution |
| 8M08 | Length 76 cm | In distribution |
| 4N12 | Length 91 cm | In distribution |
| 7K08 | Length 61 cm | In distribution |
| 5M12 | Length 76 cm | In distribution |
| 6M14 | Length 76 cm | In distribution |
| 4N10 | Length 91 cm | In distribution |
| 6M24 | Length 76 cm | In distribution |
| 4N06 | Length 91 cm | In distribution |
| 3U10 | Length 122 cm | In distribution |
| 3N08 | Length 91 cm | In distribution |
| 3N14 | Length 91 cm | In distribution |
| 6K04 | Length 61 cm | In distribution |
| 6K08 | Length 61 cm | In distribution |
| 7K02 | Length 61 cm | In distribution |
| 2N13 | Length 91 cm | In distribution |
| 2U17 | Length 122 cm | In distribution |
| 8M02 | Length 76 cm | In distribution |
| 7J04 | Length 46 cm | In distribution |
| 6J12 | Length 46 cm | In distribution |
| 3P24 | Length 107 cm | In distribution |
| 0N08 | Length 91 cm | In distribution |
| 2M25 | Length 76 cm | In distribution |
| 7M12 | Length 76 cm | In distribution |
| 6N16 | Length 91 cm | In distribution |
| 0U06 | Length 122 cm | In distribution |
| P4K13 | Length 61 cm | In distribution |
| 7M02 | Length 76 cm | In distribution |
| 7K04 | Length 61 cm | In distribution |
| 2N19 | Length 91 cm | In distribution |
| 0N13 | Length 91 cm | In distribution |
| 6M02 | Length 76 cm | In distribution |
| 2P08 | Length 107 cm | In distribution |
| 3N07 | Length 91 cm | In distribution |
| 5N06 | Length 91 cm | In distribution |
| 2N06 | Length 91 cm | In distribution |
| 8M06 | Length 76 cm | In distribution |
| 6K01 | Length 61 cm | In distribution |
| 4U02 | Length 122 cm | In distribution |
| 8J02 | Length 46 cm | In distribution |
| 5N20 | Length 91 cm | In distribution |
| 4N04 | Length 91 cm | In distribution |
| 4U06 | Length 122 cm | In distribution |
| 4U20 | Length 122 cm | In distribution |
| 2U02 | Length 122 cm | In distribution |
| 6K10 | Length 61 cm | In distribution |
| 3N04 | Length 91 cm | In distribution |
| 5M02 | Length 76 cm | In distribution |
| 3U06 | Length 122 cm | In distribution |
| 7J06 | Length 46 cm | In distribution |
| 6N04 | Length 91 cm | In distribution |
| 2N03 | Length 91 cm | In distribution |
| 2N05 | Length 91 cm | In distribution |
| 3N06 | Length 91 cm | In distribution |
| 2U06 | Length 122 cm | In distribution |
| 3N02 | Length 91 cm | In distribution |
| 0N05 | Length 91 cm | In distribution |
| 0N09 | Length 91 cm | In distribution |
| 6M08 | Length 76 cm | In distribution |
| 8K10 | Length 61 cm | In distribution |
| 4N02 | Length 91 cm | In distribution |
| 2U10 | Length 122 cm | In distribution |
| 5K12 | Length 61 cm | In distribution |
| 5N12 | Length 91 cm | In distribution |
| 0U03 | Length 122 cm | In distribution |
| 2N10 | Length 91 cm | In distribution |
| 0U01 | Length 122 cm | In distribution |
| 7K06 | Length 61 cm | In distribution |
| 4N08 | Length 91 cm | In distribution |
| 7M08 | Length 76 cm | In distribution |
| 2N23 | Length 91 cm | In distribution |
| 5N04 | Length 91 cm | In distribution |
| 3U08 | Length 122 cm | In distribution |
| 7M04 | Length 76 cm | In distribution |
| 3202 | Length 91 cm | Withdrawn |
| M2U28 | Length 122 cm | Withdrawn |
| 3201 | Length 91 cm | Withdrawn |
| 3200 | Length 91 cm | 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 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
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.