FDA 510(k) Applications for Medical Device Product Code "GAR"
(Suture, Nonabsorbable, Synthetic, Polyamide)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K151165 | AESCULAP, INC. | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | 02/17/2016 |
| K060528 | AESCULAP, INC. | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | 03/28/2006 |
| K990090 | AESCULAP, INC. | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE | 03/22/1999 |
| K212888 | Antarma LLC dba Golnit Sutures | Golnit Nylon Monofilament Suture | 03/31/2022 |
| K000539 | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. | NYLON NONABSORBABLE SURGICAL SUTURES, USP | 04/27/2000 |
| K042367 | AROS SURGICAL INSTRUMENTS CORP. | NYLON THREADED NEEDLE | 10/14/2004 |
| K032160 | ARTIMPLANT AB | ARTELON SURGICAL SUTURE | 11/17/2003 |
| K052482 | ARTIMPLANT AB | ARTELON SURGICAL SUTURE | 10/17/2005 |
| K024090 | AUROLAB | NYLON SUTURE | 02/28/2003 |
| K001173 | CP MEDICAL | NYLON, NONABSORBABLE SURGICAL SUTURES USP | 06/23/2000 |
| K981582 | DAVIS & GECK, INC. | SURGILON, DERMALON, & OPHTHALON | 07/13/1998 |
| K023028 | DEMETECH CORP. | DEMETECH NYLON NONABSORBABLE SUTURE | 06/18/2003 |
| K060471 | FSSB CHIRURGISCHE NADELN GMBH | FSSB NYLON SURGICAL SUTURES | 07/26/2006 |
| K981322 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | 07/07/1998 |
| K003000 | GRAMSMED LLC | GRAMS NYLON NONABSORBABLE SUTURE | 12/18/2000 |
| K192420 | Kono Seisakusho Co., Ltd. | Crownjun Nylon Suture | 05/29/2020 |
| K053637 | MANI, INC. | MANI NEEDLE & SUTURE PACK (NYLON) | 05/19/2006 |
| K993970 | MICRINS SURGICAL, INC. | MICRINS MICROSURGICAL SUTURE | 03/30/2000 |
| K081366 | NASHVILLE SURGICAL INSTRUMENTS | KUMAR T-ANCHORS HERNIA SET | 07/15/2008 |
| K052900 | QUILL MEDICAL, INC. | QUILL NONABSORBABLE NYLON BARBED SUTURE | 11/28/2005 |
| K960327 | R.K. MEDICAL, L.L.C. | NYLON NOABSORBABLE SURGICAL SUTURES USP | 03/04/1996 |
| K152795 | RIVERPOINT MEDICAL | RiverLon (Nylon) Suture | 10/28/2015 |
| K031531 | S & T AG | S&T MICROSURGICAL SUTURE | 09/23/2003 |
| K020146 | SERRAL, S.A. DE C.V. | SERRALNYL | 04/15/2002 |
| K212603 | Shandong Haidike Medical Product Co., Ltd. | Non Absorbable Surgical Nylon Suture | 12/22/2021 |
| K161633 | SM ENG CO., LTD | REXLON, REXSIL | 03/02/2017 |
| K030177 | SRI ORION PHARMACEUTICALS & SUTURES | ORLON NONABSORABLE SURGICAL SUTURE USP | 07/21/2003 |
| K041510 | SUTURES INDIA PRIVATE LIMITED | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | 06/02/2005 |
| K220980 | TAS Medical, Inc. | Tissue Approximation System (TAS) | 07/05/2023 |
| K993998 | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. | NYLON | 02/04/2000 |
| K123034 | UNILENE S.A.C. | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | 05/28/2013 |
| K042284 | UNITED MEDICAL INDUSTRIES CO. LTD. | UNIMIDE | 12/03/2004 |
| K994176 | VISIONARY MEDICAL SUPPLIES, INC. | SUTRALON NYLON SUTURES | 02/08/2000 |
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