FDA Product Code
FDA Product Code GAR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5020
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261484 | Tissue Approximation System | Tas Medical, Inc. | 2026-06-03 | Special | PDF ↗ |
| K220980 | Tissue Approximation System (TAS) | Tas Medical, Inc. | 2023-07-05 | Traditional | PDF ↗ |
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022-03-31 | Abbreviated | PDF ↗ |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020-05-29 | Traditional | PDF ↗ |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017-03-02 | Traditional | PDF ↗ |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016-02-17 | Traditional | PDF ↗ |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical | 2015-10-28 | Special | PDF ↗ |
| K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | Unilene Sac | 2013-05-28 | Traditional | PDF ↗ |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | 2008-07-15 | Traditional | PDF ↗ |
| K060471 | FSSB NYLON SURGICAL SUTURES | Fssb Chirurgische Nadeln GmbH | 2006-07-26 | Abbreviated | PDF ↗ |
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | 2006-05-19 | Traditional | PDF ↗ |
| K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 2006-03-28 | Special | PDF ↗ |
| K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE | Quill Medical, Inc. | 2005-11-28 | Abbreviated | PDF ↗ |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | 2005-10-17 | Special | PDF ↗ |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-02 | Traditional | PDF ↗ |
| K042284 | UNIMIDE | United Medical Industries Co. , Ltd. | 2004-12-03 | Traditional | PDF ↗ |
| K042367 | NYLON THREADED NEEDLE | Aros Surgical Instruments Corp. | 2004-10-14 | Abbreviated | PDF ↗ |
| K032160 | ARTELON SURGICAL SUTURE | Artimplant AB | 2003-11-17 | Traditional | PDF ↗ |
| K031531 | S&T MICROSURGICAL SUTURE | S & T AG | 2003-09-23 | Traditional | PDF ↗ |
| K030177 | ORLON NONABSORABLE SURGICAL SUTURE USP | Sri Orion Pharmaceuticals & Sutures | 2003-07-21 | Abbreviated | PDF ↗ |
| K023028 | DEMETECH NYLON NONABSORBABLE SUTURE | Demetech Corp. | 2003-06-18 | Traditional | PDF ↗ |
| K024090 | NYLON SUTURE | Aurolab | 2003-02-28 | Traditional | PDF ↗ |
| K020146 | SERRALNYL | Serral, S.A. DE C.V. | 2002-04-15 | Traditional | PDF ↗ |
| K003000 | GRAMS NYLON NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-18 | Traditional | PDF ↗ |
| K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 | Traditional | PDF ↗ |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | Traditional | PDF ↗ |
| K993970 | MICRINS MICROSURGICAL SUTURE | Micrins Surgical, Inc. | 2000-03-30 | Traditional | PDF ↗ |
| K994176 | SUTRALON NYLON SUTURES | Visionary Medical Supplies, Inc. | 2000-02-08 | Traditional | PDF ↗ |
| K993998 | NYLON | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K990090 | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 1999-03-22 | Traditional | PDF ↗ |
| K981582 | SURGILON, DERMALON, & OPHTHALON | Davis & Geck, Inc. | 1998-07-13 | Traditional | PDF ↗ |
| K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-07-07 | Traditional | PDF ↗ |
| K960327 | NYLON NOABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 | Traditional | PDF ↗ |
| K943216 | SURGIDEK | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K943223 | SURGIDEK B | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K943222 | SURGIDEK S | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K931914 | SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE | Surgimetrics International, Ltd. | 1994-10-05 | Traditional | PDF ↗ |
| K932037 | SUTURE ABSORBABLE- GUT | Surgical Specialties, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930586 | DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT | Davis & Geck, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K926168 | SILK SUTURES-REVISED LABELING | Look, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K926587 | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) | Look, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K931613 | SUPRAMID SUTURE | S. Jackson, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K931612 | NYLAMID SUTURE | S. Jackson, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K930943 | LUKENS NYLON SURGICAL SUTURE | Lukens Medical Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K930517 | NON-ABSORBABLE SURGICAL SUTURES | Alcon Laboratories | 1993-12-17 | Traditional | PDF ↗ |
| K922530 | VISITEC MICROSURGICAL SUTURE | Visitec Co. | 1992-10-20 | Traditional | PDF ↗ |
| K920510 | URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER | Uresil Corp. | 1992-09-14 | Traditional | PDF ↗ |
| K913102 | PETERS CARDIONYL(TM) SUTURE | Promedica Products, Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K912429 | N80-838 SUPRAMID EXTRA SUTURE | S. Jackson, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K903177 | ADVANCE SUTURE NONABSORBABLE NYLON SUTURE | Advance Suture, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K905286 | IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 | Traditional | PDF ↗ |
| K904931 | AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* | United States Surgical, A Division of Tyco Healthc | 1991-01-29 | Traditional | PDF ↗ |
| K905379 | AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP | United States Surgical, A Division of Tyco Healthc | 1991-01-17 | Traditional | PDF ↗ |
| K904052 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1990-10-25 | Traditional | PDF ↗ |
| K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | Look, Inc. | 1990-10-25 | Traditional | PDF ↗ |
| K900531 | NONABSORBABLE NYLON SURGICAL SUTURE* | United States Surgical, A Division of Tyco Healthc | 1990-07-05 | Traditional | PDF ↗ |
Product code GAR · Class II · General, Plastic Surgery. Data: openFDA.