Panels › General, Plastic Surgery › Product code GAR · Class 2
Suture, Nonabsorbable, Synthetic, Polyamide
Regulation 878.5020
1510(k)s in 12 months (57 all time)
1recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in GAR
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LP | 0 | 6 |
| Aesculap, Inc. | 3 | 1 |
| S. Jackson, Inc. | 4 | 0 |
| Look, Inc. | 3 | 0 |
| Riverpoint Medical | 1 | 2 |
| Surgical Specialties, Inc. | 1 | 2 |
| Sutures , Ltd. | 3 | 0 |
| Tas Medical, Inc. | 2 | 1 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Artimplant AB | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2026 | K261484 | Tissue Approximation System Tas Medical, Inc. | GAR |
| Jul 5, 2023 | K220980 | Tissue Approximation System (TAS) Tas Medical, Inc. | GAR |
| Mar 31, 2022 | K212888 | Golnit Nylon Monofilament Suture Antarma, LLC Dba Golnit Sutures | GAR |
| Dec 22, 2021 | K212603 | Non Absorbable Surgical Nylon Suture Shandong Haidike Medical Product Co., Ltd., CN | GAR |
| May 29, 2020 | K192420 | Crownjun Nylon Suture Kono Seisakusho Co., Ltd., JP | GAR |
| Mar 2, 2017 | K161633 | REXLON, REXSIL Sm Eng Co., Ltd., KR | GAR |
| Feb 17, 2016 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture Aesculap, Inc. | GAR |
| Oct 28, 2015 | K152795 | RiverLon (Nylon) Suture Riverpoint Medical | GAR |
| May 28, 2013 | K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED Unilene Sac | GAR |
| Jul 15, 2008 | K081366 | KUMAR T-ANCHORS HERNIA SET Nashville Surgical Instruments | GAR |
| Jul 26, 2006 | K060471 | FSSB NYLON SURGICAL SUTURES Fssb Chirurgische Nadeln GmbH | GAR |
| May 19, 2006 | K053637 | MANI NEEDLE & SUTURE PACK (NYLON) Mani, Inc. | GAR |
| Mar 28, 2006 | K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE Aesculap, Inc. | GAR |
| Nov 28, 2005 | K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE Quill Medical, Inc. | GAR |
| Oct 17, 2005 | K052482 | ARTELON SURGICAL SUTURE Artimplant AB | GAR |
| Jun 2, 2005 | K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE Sutures India Private Limited, IN | GAR |
| Dec 3, 2004 | K042284 | UNIMIDE United Medical Industries Co. , Ltd., SA | GAR |
| Oct 14, 2004 | K042367 | NYLON THREADED NEEDLE Aros Surgical Instruments Corp. | GAR |
| Nov 17, 2003 | K032160 | ARTELON SURGICAL SUTURE Artimplant AB | GAR |
| Sep 23, 2003 | K031531 | S&T MICROSURGICAL SUTURE S & T AG | GAR |
| Jul 21, 2003 | K030177 | ORLON NONABSORABLE SURGICAL SUTURE USP Sri Orion Pharmaceuticals & Sutures | GAR |
| Jun 18, 2003 | K023028 | DEMETECH NYLON NONABSORBABLE SUTURE Demetech Corp. | GAR |
| Feb 28, 2003 | K024090 | NYLON SUTURE Aurolab | GAR |
| Apr 15, 2002 | K020146 | SERRALNYL Serral, S.A. DE C.V. | GAR |
| Dec 18, 2000 | K003000 | GRAMS NYLON NONABSORBABLE SUTURE Gramsmed, LLC | GAR |
| Jun 23, 2000 | K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP Cp Medical | GAR |
| Apr 27, 2000 | K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP Arc Medical Supplies (Beijing) Co, Ltd. | GAR |
| Mar 30, 2000 | K993970 | MICRINS MICROSURGICAL SUTURE Micrins Surgical, Inc. | GAR |
| Feb 8, 2000 | K994176 | SUTRALON NYLON SUTURES Visionary Medical Supplies, Inc. | GAR |
| Feb 4, 2000 | K993998 | NYLON Trading Consultants and Distributors Intl., Inc. | GAR |
| Mar 22, 1999 | K990090 | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE Aesculap, Inc. | GAR |
| Jul 13, 1998 | K981582 | SURGILON, DERMALON, & OPHTHALON Davis & Geck, Inc. | GAR |
| Jul 7, 1998 | K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAR |
| Mar 4, 1996 | K960327 | NYLON NOABSORBABLE SURGICAL SUTURES USP R. K. Medical L. L. C. | GAR |
| Dec 5, 1994 | K943223 | SURGIDEK B Sutures , Ltd., GB | GAR |
| Dec 5, 1994 | K943222 | SURGIDEK S Sutures , Ltd., GB | GAR |
| Dec 5, 1994 | K943216 | SURGIDEK Sutures , Ltd., GB | GAR |
| Oct 5, 1994 | K931914 | SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE Surgimetrics International, Ltd. | GAR |
| Jan 7, 1994 | K932037 | SUTURE ABSORBABLE- GUT Surgical Specialties, Inc. | GAR |
| Dec 17, 1993 | K931613 | SUPRAMID SUTURE S. Jackson, Inc. | GAR |
| Dec 17, 1993 | K931612 | NYLAMID SUTURE S. Jackson, Inc. | GAR |
| Dec 17, 1993 | K930943 | LUKENS NYLON SURGICAL SUTURE Lukens Medical Corp. | GAR |
| Dec 17, 1993 | K930586 | DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT Davis & Geck, Inc. | GAR |
| Dec 17, 1993 | K930517 | NON-ABSORBABLE SURGICAL SUTURES Alcon Laboratories | GAR |
| Dec 17, 1993 | K926587 | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) Look, Inc. | GAR |
| Dec 17, 1993 | K926168 | SILK SUTURES-REVISED LABELING Look, Inc. | GAR |
| Oct 20, 1992 | K922530 | VISITEC MICROSURGICAL SUTURE Visitec Co. | GAR |
| Sep 14, 1992 | K920510 | URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER Uresil Corp. | GAR |
| Aug 3, 1992 | K913102 | PETERS CARDIONYL(TM) SUTURE Promedica Products, Inc. | GAR |
| Oct 2, 1991 | K912429 | N80-838 SUPRAMID EXTRA SUTURE S. Jackson, Inc. | GAR |
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