Wego-Silk Non-Absorbable Surgical Suture With Needle
404 catalogue numbers from S53203, listed by Foosin Medical Supplies Inc.ltd, China, under Suture, Nonabsorbable, Silk. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
404catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| 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 | Foosin Medical Supplies Inc.ltd, China |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| Establishment | Manufacturer |
| 510(k) | K080684 |
| Record published | 2015-09-28 |
| Record revised | 2021-09-27 (version 6) |
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 |
| Distribution end date | 2021-09-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S53203 | In distribution | |
| S47172 | In distribution | |
| S53162 | In distribution | |
| S43123 | In distribution | |
| S47173 | In distribution | |
| S51202 | In distribution | |
| S51192 | In distribution | |
| S43243 | In distribution | |
| S43500 | In distribution | |
| S43222 | In distribution | |
| S53123 | In distribution | |
| S43202 | In distribution | |
| S41182 | In distribution | |
| S51163 | In distribution | |
| S43182 | In distribution | |
| S43172 | In distribution | |
| S43153 | In distribution | |
| S36263-45 | In distribution | |
| S43162 | In distribution | |
| S44242 | In distribution | |
| S51162 | In distribution | |
| S47222 | In distribution | |
| S43263 | In distribution | |
| S43203 | In distribution | |
| S26263-45 | In distribution | |
| S53193 | In distribution | |
| S43193S | In distribution | |
| S43223 | In distribution | |
| S51132 | In distribution | |
| S51172 | In distribution | |
| S43303 | In distribution | |
| S51262 | In distribution | |
| S43212 | In distribution | |
| S53182 | In distribution | |
| S43193 | In distribution | |
| S53163 | In distribution | |
| S43133 | In distribution | |
| S56163 | In distribution | |
| S44193 | In distribution | |
| S43480 | In distribution | |
| S43293 | In distribution | |
| S43173 | In distribution | |
| S51183 | In distribution | |
| S53222 | In distribution | |
| S46193-45 | In distribution | |
| S53242 | In distribution | |
| S43262 | In distribution | |
| S51182 | In distribution | |
| S54163 | In distribution | |
| S43143 | In distribution | |
| S43253 | In distribution | |
| S51222 | In distribution | |
| S44183 | In distribution | |
| S53133 | In distribution | |
| S43183 | In distribution | |
| S36193-45 | In distribution | |
| S53153 | In distribution | |
| S33242-45 | In distribution | |
| S43163 | In distribution | |
| S43183S | In distribution | |
| S54182 | In distribution | |
| S43192 | In distribution | |
| S44173 | In distribution | |
| S3006013 | Withdrawn | |
| S33173 | Withdrawn | |
| SB018001 | Withdrawn | |
| S2006010 | Withdrawn | |
| S17262 | Withdrawn | |
| S27252 | Withdrawn | |
| SB3263 | Withdrawn | |
| S33202 | Withdrawn | |
| S14482 | Withdrawn | |
| S63163 | Withdrawn | |
| SC010001 | Withdrawn | |
| S41262 | Withdrawn | |
| S61202 | Withdrawn | |
| S2006006 | Withdrawn | |
| S73083D | Withdrawn | |
| S37193 | Withdrawn | |
| S23550 | Withdrawn | |
| SB4442 | Withdrawn | |
| SB1372 | Withdrawn | |
| S41263 | Withdrawn | |
| S41162 | Withdrawn | |
| S13373 | Withdrawn | |
| S14363 | Withdrawn | |
| S2507510 | Withdrawn | |
| S31302 | Withdrawn | |
| S88063 | Withdrawn | |
| S21372 | Withdrawn | |
| SB3522 | Withdrawn | |
| S1006008 | Withdrawn | |
| S41202 | Withdrawn | |
| SC4332U | Withdrawn | |
| S13323 | Withdrawn | |
| S34243 | Withdrawn | |
| S3015001 | Withdrawn | |
| S34253 | Withdrawn | |
| S23172 | Withdrawn | |
| SB1312 | Withdrawn | |
| S3X222 | Withdrawn | |
| SB006013 | Withdrawn | |
| S21312 | Withdrawn | |
| S23242 | Withdrawn | |
| S23303 | Withdrawn | |
| SB3373 | Withdrawn | |
| S27193 | Withdrawn | |
| S13402 | Withdrawn | |
| SB1482 | Withdrawn | |
| S23580 | Withdrawn | |
| SC1642 | Withdrawn | |
| S21302 | Withdrawn | |
| S41183 | Withdrawn | |
| SB004517 | Withdrawn | |
| S2004510 | Withdrawn | |
| S11372 | Withdrawn | |
| S33193 | Withdrawn | |
| S3006010 | Withdrawn | |
| S23333 | Withdrawn | |
| S13600 | Withdrawn | |
| S33213 | Withdrawn | |
| S33253 | Withdrawn | |
| SB1262 | Withdrawn | |
| S13372H | Withdrawn | |
| SC3402 | Withdrawn | |
| SB3353 | Withdrawn | |
| SB004506 | Withdrawn | |
| S24203 | Withdrawn | |
| S23233 | Withdrawn | |
| S37262 | Withdrawn | |
| S64123D | Withdrawn | |
| S21402 | Withdrawn | |
| S13903 | Withdrawn | |
| S1007506 | Withdrawn | |
| S2007510 | Withdrawn | |
| S41172 | Withdrawn | |
| SC1362 | Withdrawn | |
| S23372 | Withdrawn | |
| S33550 | Withdrawn | |
| S23313 | Withdrawn | |
| S64162 | Withdrawn | |
| S63193 | Withdrawn | |
| S23402 | Withdrawn | |
| S41152 | Withdrawn | |
| S37172 | Withdrawn | |
| S26243 | Withdrawn | |
| SB3453 | Withdrawn | |
| S23322 | Withdrawn | |
| S13383 | Withdrawn | |
| S4007510 | Withdrawn | |
| S31272 | Withdrawn | |
| S63103 | Withdrawn | |
| S23353 | Withdrawn | |
| S33353 | Withdrawn | |
| S2006015 | Withdrawn | |
| S88063D | Withdrawn | |
| S37222 | Withdrawn | |
| S21262 | Withdrawn | |
| SB3403 | Withdrawn | |
| SB3303 | Withdrawn | |
| SB1322 | Withdrawn | |
| S1007510 | Withdrawn | |
| SD3453 | Withdrawn | |
| S23302 | Withdrawn | |
| S23403 | Withdrawn | |
| S33252 | Withdrawn | |
| S2007506 | Withdrawn | |
| S21183 | Withdrawn | |
| SC3502 | Withdrawn | |
| S4018001 | Withdrawn | |
| S41132 | Withdrawn | |
| S11222 | Withdrawn | |
| SB3580 | Withdrawn | |
| SC1372 | Withdrawn | |
| SB3383 | Withdrawn | |
| S27172 | Withdrawn | |
| S33203 | Withdrawn | |
| S61222 | Withdrawn | |
| S13302 | Withdrawn | |
| S37192 | Withdrawn | |
| S11312 | Withdrawn | |
| S31172 | Withdrawn | |
| SB007506 | Withdrawn | |
| S4006006 | Withdrawn | |
| S1006013 | Withdrawn | |
| S13403 | Withdrawn | |
| S3007510 | Withdrawn | |
| S63113 | Withdrawn | |
| S37173 | Withdrawn | |
| S57172 | Withdrawn | |
| S14303 | Withdrawn | |
| S24383 | Withdrawn | |
| SB006006 | Withdrawn | |
| S2018001 | Withdrawn | |
| SB1302 | Withdrawn | |
| SB1362 | Withdrawn | |
| SB1382 | Withdrawn | |
| S1006010 | Withdrawn | |
| S34263 | Withdrawn | |
| S33243 | Withdrawn | |
| SC3382 | Withdrawn | |
| S11352 | Withdrawn | |
| S17362 | Withdrawn | |
| S31382 | Withdrawn | |
| SB3273 | Withdrawn | |
| S33183 | Withdrawn | |
| S11482 | Withdrawn | |
| S2006001 | Withdrawn | |
| S4015001 | Withdrawn | |
| S13303 | Withdrawn | |
| S34222 | Withdrawn | |
| SC3403 | Withdrawn | |
| SC015001 | Withdrawn | |
| S1015001 | Withdrawn | |
| S41252 | Withdrawn | |
| SC1502 | Withdrawn | |
| SC004502 | Withdrawn | |
| S1018001 | Withdrawn | |
| S23243 | Withdrawn | |
| S2004517 | Withdrawn | |
| SC3453 | Withdrawn | |
| S33172 | Withdrawn | |
| SC1393 | Withdrawn | |
| S23500 | Withdrawn | |
| S73123 | Withdrawn | |
| S21552 | Withdrawn | |
| S21322 | Withdrawn | |
| SC3903 | Withdrawn | |
| S63123 | Withdrawn | |
| S4006010 | Withdrawn | |
| S23262 | Withdrawn | |
| S33162 | Withdrawn | |
| SC004517 | Withdrawn | |
| S31262 | Withdrawn | |
| S61133 | Withdrawn | |
| S33363 | Withdrawn | |
| S33212 | Withdrawn | |
| S33192 | Withdrawn | |
| S23383 | Withdrawn | |
| S21172 | Withdrawn | |
| S2004512 | Withdrawn | |
| S21262H | Withdrawn | |
| SB7362 | Withdrawn | |
| SB1352 | Withdrawn | |
| S24353 | Withdrawn | |
| S4004517 | Withdrawn | |
| S1006015 | Withdrawn | |
| S31163 | Withdrawn | |
| S24363 | Withdrawn | |
| SB006010 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeSILK | Demetech Corp. | 1,198 |
| Silkam | B Braun Surgical SA | 632 |
| Sofsilk | Covidien LP | 319 |
| Perma-Hand | Ethicon, Inc. | 231 |
| Deknatel | Teleflex Medical LLC | 109 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 100 |
| Mani Sutures Silk | Mani, Inc. | 75 |
| Suture, Nonabsorbable, Silk | C P Medical Inc. | 48 |
| Sutumed | Unilene S.A.C. | 44 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 36 |
| Silk | Resorba Medical GmbH | 35 |
| Rtmed | Shandong Haidike Medical Products Co., Ltd. | 34 |
Showing 12 of 205. All products under Suture, Nonabsorbable, Silk
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080684 | 2008-06-09 |
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 |
|---|---|---|---|
| N80989 | 1989-08-01 | SILK SUTURES | Lukens Corp. |
| N84348 | 1989-06-16 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. |
| N85143 | 1987-04-03 | SUTURES | Sharpoint, Inc. |
| N11397 | 1982-12-08 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | Ethicon, Inc. |
| N84047 | 1982-07-16 | SILK NONABSORBABLE SUTURES, USP | 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.