Wego-Pgla Absorbable Surgical Suture With Needle
WEGO-PGLA is a braided, synthetic absorbable surgical suture supplied with a needle. It is used to bring soft tissue edges together or to ligate tissue, including during ophthalmic…
WEGO-PGLA is a braided, synthetic absorbable surgical suture supplied with a needle. It is used to bring soft tissue edges together or to ligate tissue, including during ophthalmic procedures. It is not intended for cardiovascular or neural tissue.
The suture is made from a copolymer containing 90% glycolide and 10% L-lactide. It has a coating of glycolide-lactide copolymer and calcium stearate, and is available in dyed or undyed forms with stainless steel needles.
Sterile Supply
The suture and needle are supplied sterile following ethylene oxide sterilization and are intended for a single use. The absorbable suture is offered in several thread sizes and lengths.
4manufacturers in China registered for this device type
180catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | Foosin Medical Supplies Inc.ltd, China |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Manufacturer |
| 510(k) | K130735 |
| Record published | 2016-04-13 |
| Record revised | 2021-09-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
| Distribution end date | 2021-09-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4-45 x 6 | In distribution | |
| A3-45 x 6 | In distribution | |
| A43202 | Withdrawn | |
| A31302 | Withdrawn | |
| A11252 | Withdrawn | |
| AB3482 | Withdrawn | |
| A31402 | Withdrawn | |
| A43203 | Withdrawn | |
| A51152 | Withdrawn | |
| AB4040 | Withdrawn | |
| AB1452 | Withdrawn | |
| A1004503 | Withdrawn | |
| AB1362 | Withdrawn | |
| AB1372 | Withdrawn | |
| A11402 | Withdrawn | |
| A13482H | Withdrawn | |
| A1015001 | Withdrawn | |
| A17482 | Withdrawn | |
| A21262 | Withdrawn | |
| A33243U | Withdrawn | |
| A43193 | Withdrawn | |
| A53123 | Withdrawn | |
| A23303 | Withdrawn | |
| AC3402 | Withdrawn | |
| A33193 | Withdrawn | |
| A11382 | Withdrawn | |
| A4004512 | Withdrawn | |
| A13303 | Withdrawn | |
| A37172 | Withdrawn | |
| AB3303 | Withdrawn | |
| A53163 | Withdrawn | |
| A53163 | Withdrawn | |
| A31312 | Withdrawn | |
| A61163 | Withdrawn | |
| A2018001 | Withdrawn | |
| AC3482 | Withdrawn | |
| A53193 | Withdrawn | |
| AB1482 | Withdrawn | |
| A13262 | Withdrawn | |
| A2025001 | Withdrawn | |
| A31262H | Withdrawn | |
| A53172U | Withdrawn | |
| A43163H | Withdrawn | |
| A23372H | Withdrawn | |
| AB1302 | Withdrawn | |
| AB004506 | Withdrawn | |
| A21222 | Withdrawn | |
| A31262 | Withdrawn | |
| A13372 | Withdrawn | |
| A21372 | Withdrawn | |
| A33203 | Withdrawn | |
| AB3403 | Withdrawn | |
| A2004512 | Withdrawn | |
| A33172U | Withdrawn | |
| AB2643 | Withdrawn | |
| A33192 | Withdrawn | |
| A33243 | Withdrawn | |
| A11482 | Withdrawn | |
| AB3302 | Withdrawn | |
| A21312 | Withdrawn | |
| A11302 | Withdrawn | |
| A31172 | Withdrawn | |
| A61132U | Withdrawn | |
| A13453 | Withdrawn | |
| A23243 | Withdrawn | |
| A51172 | Withdrawn | |
| AB018001 | Withdrawn | |
| A3004506 | Withdrawn | |
| A41172 | Withdrawn | |
| A21402 | Withdrawn | |
| A33263H | Withdrawn | |
| A43243 | Withdrawn | |
| A13262H | Withdrawn | |
| A23372 | Withdrawn | |
| A68084D | Withdrawn | |
| A31262U | Withdrawn | |
| A2007502 | Withdrawn | |
| A51182 | Withdrawn | |
| A31222 | Withdrawn | |
| AC1482 | Withdrawn | |
| A1004506 | Withdrawn | |
| A1004512 | Withdrawn | |
| A43132U | Withdrawn | |
| A41152 | Withdrawn | |
| A51132 | Withdrawn | |
| A41202 | Withdrawn | |
| AC1402 | Withdrawn | |
| A3004512 | Withdrawn | |
| AB3363 | Withdrawn | |
| A14303 | Withdrawn | |
| A3004503 | Withdrawn | |
| A23402 | Withdrawn | |
| A23222 | Withdrawn | |
| A27262 | Withdrawn | |
| AB004503 | Withdrawn | |
| A37262 | Withdrawn | |
| A11362 | Withdrawn | |
| A24202 | Withdrawn | |
| A41252 | Withdrawn | |
| AC015001 | Withdrawn | |
| AB015001 | Withdrawn | |
| A1007502 | Withdrawn | |
| A37223 | Withdrawn | |
| A63123 | Withdrawn | |
| AB3482H | Withdrawn | |
| A47223 | Withdrawn | |
| AC004506 | Withdrawn | |
| A43263 | Withdrawn | |
| A33402H | Withdrawn | |
| AB3362 | Withdrawn | |
| AB1312 | Withdrawn | |
| A13402 | Withdrawn | |
| A43133 | Withdrawn | |
| A51162 | Withdrawn | |
| A11262 | Withdrawn | |
| A78082D | Withdrawn | |
| AB1502 | Withdrawn | |
| A4004506 | Withdrawn | |
| A23303H | Withdrawn | |
| A33302H | Withdrawn | |
| A43193U | Withdrawn | |
| A31132 | Withdrawn | |
| A41132 | Withdrawn | |
| A31382 | Withdrawn | |
| AB3402 | Withdrawn | |
| A58113UD | Withdrawn | |
| A31252 | Withdrawn | |
| AB1482H | Withdrawn | |
| A61132 | Withdrawn | |
| AB007002 | Withdrawn | |
| A3018001 | Withdrawn | |
| A33303 | Withdrawn | |
| A43163 | Withdrawn | |
| A13363 | Withdrawn | |
| A68133UD | Withdrawn | |
| A17362 | Withdrawn | |
| A27382 | Withdrawn | |
| A3007502 | Withdrawn | |
| A23193 | Withdrawn | |
| A43172U | Withdrawn | |
| A33243H | Withdrawn | |
| A31202 | Withdrawn | |
| A88063D | Withdrawn | |
| A1018001 | Withdrawn | |
| A53132U | Withdrawn | |
| A11262H | Withdrawn | |
| A11652 | Withdrawn | |
| A11482H | Withdrawn | |
| A41262 | Withdrawn | |
| A21252 | Withdrawn | |
| A13362 | Withdrawn | |
| A27272 | Withdrawn | |
| A21362 | Withdrawn | |
| A61152 | Withdrawn | |
| A24302 | Withdrawn | |
| A43133HU | Withdrawn | |
| A78063D | Withdrawn | |
| AC1452 | Withdrawn | |
| AB004512 | Withdrawn | |
| A47172 | Withdrawn | |
| A61172 | Withdrawn | |
| A43450 | Withdrawn | |
| A44253 | Withdrawn | |
| A2004506 | Withdrawn | |
| A11372H | Withdrawn | |
| AC004512 | Withdrawn | |
| AB1402 | Withdrawn | |
| A2004503 | Withdrawn | |
| A4015001 | Withdrawn | |
| A51122 | Withdrawn | |
| A33193U | Withdrawn | |
| AB7402 | Withdrawn | |
| A41222 | Withdrawn | |
| A58084D | Withdrawn | |
| A31372 | Withdrawn | |
| A3025001 | Withdrawn | |
| A11372 | Withdrawn | |
| A21302 | Withdrawn | |
| A17362U | Withdrawn | |
| A63103 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183004 | 2019-01-28 |
| K183001 | 2019-01-28 |
| K142810 | 2014-11-14 |
| K130737 | 2014-01-14 |
| K130735 | 2014-01-14 |
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 |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | Davis & Geck, 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.