Atlas FDA

GAR

57 FDA 510(k) clearances · Product code

131 daysmedian time to decision
360 days90th percentile
57clearances measured

FDA profile

Official device name
Suture, Nonabsorbable, Synthetic, Polyamide
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5020
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 532 · 2022: 549 · 2023: 607 · 2024: 668 · 2025: 829 · 2026: 658
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Tissue Approximation System (K261484)Tas Medical, Inc.2026-06-03
Tissue Approximation System (TAS) (K220980)Tas Medical, Inc.2023-07-05
Golnit Nylon Monofilament Suture (K212888)Antarma, LLC Dba Golnit Sutures2022-03-31
Non Absorbable Surgical Nylon Suture (K212603)Shandong Haidike Medical Product Co., Ltd.2021-12-22
Crownjun Nylon Suture (K192420)Kono Seisakusho Co., Ltd.2020-05-29
REXLON, REXSIL (K161633)Sm Eng Co., Ltd.2017-03-02
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (K151165)Aesculap, Inc.2016-02-17
RiverLon (Nylon) Suture (K152795)Riverpoint Medical2015-10-28
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (K123034)Unilene Sac2013-05-28
KUMAR T-ANCHORS HERNIA SET (K081366)Nashville Surgical Instruments2008-07-15
FSSB NYLON SURGICAL SUTURES (K060471)Fssb Chirurgische Nadeln GmbH2006-07-26
MANI NEEDLE & SUTURE PACK (NYLON) (K053637)Mani, Inc.2006-05-19
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE (K060528)Aesculap, Inc.2006-03-28
QUILL NONABSORBABLE NYLON BARBED SUTURE (K052900)Quill Medical, Inc.2005-11-28
ARTELON SURGICAL SUTURE (K052482)Artimplant AB2005-10-17
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE (K041510)Sutures India Private Limited2005-06-02
UNIMIDE (K042284)United Medical Industries Co. , Ltd.2004-12-03
NYLON THREADED NEEDLE (K042367)Aros Surgical Instruments Corp.2004-10-14
ARTELON SURGICAL SUTURE (K032160)Artimplant AB2003-11-17
S&T MICROSURGICAL SUTURE (K031531)S & T AG2003-09-23
ORLON NONABSORABLE SURGICAL SUTURE USP (K030177)Sri Orion Pharmaceuticals & Sutures2003-07-21
DEMETECH NYLON NONABSORBABLE SUTURE (K023028)Demetech Corp.2003-06-18
NYLON SUTURE (K024090)Aurolab2003-02-28
SERRALNYL (K020146)Serral, S.A. DE C.V.2002-04-15
GRAMS NYLON NONABSORBABLE SUTURE (K003000)Gramsmed, LLC2000-12-18
NYLON, NONABSORBABLE SURGICAL SUTURES USP (K001173)Cp Medical2000-06-23
NYLON NONABSORBABLE SURGICAL SUTURES, USP (K000539)Arc Medical Supplies (Beijing) Co, Ltd.2000-04-27
MICRINS MICROSURGICAL SUTURE (K993970)Micrins Surgical, Inc.2000-03-30
SUTRALON NYLON SUTURES (K994176)Visionary Medical Supplies, Inc.2000-02-08
NYLON (K993998)Trading Consultants and Distributors Intl., Inc.2000-02-04
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE (K990090)Aesculap, Inc.1999-03-22
SURGILON, DERMALON, & OPHTHALON (K981582)Davis & Geck, Inc.1998-07-13
CUTALON NYLON POLYAMIDE SURGICAL SUTURE (K981322)Genzyme Surgical Product (Genzyme Biosurgery)1998-07-07
NYLON NOABSORBABLE SURGICAL SUTURES USP (K960327)R. K. Medical L. L. C.1996-03-04
SURGIDEK (K943216)Sutures , Ltd.1994-12-05
SURGIDEK B (K943223)Sutures , Ltd.1994-12-05
SURGIDEK S (K943222)Sutures , Ltd.1994-12-05
SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE (K931914)Surgimetrics International, Ltd.1994-10-05
SUTURE ABSORBABLE- GUT (K932037)Surgical Specialties, Inc.1994-01-07
LUKENS NYLON SURGICAL SUTURE (K930943)Lukens Medical Corp.1993-12-17
NYLAMID SUTURE (K931612)S. Jackson, Inc.1993-12-17
DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT (K930586)Davis & Geck, Inc.1993-12-17
NON-ABSORBABLE SURGICAL SUTURES (K930517)Alcon Laboratories1993-12-17
SUPRAMID SUTURE (K931613)S. Jackson, Inc.1993-12-17
SILK SUTURES-REVISED LABELING (K926168)Look, Inc.1993-12-17
REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (K926587)Look, Inc.1993-12-17
VISITEC MICROSURGICAL SUTURE (K922530)Visitec Co.1992-10-20
URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER (K920510)Uresil Corp.1992-09-14
PETERS CARDIONYL(TM) SUTURE (K913102)Promedica Products, Inc.1992-08-03
N80-838 SUPRAMID EXTRA SUTURE (K912429)S. Jackson, Inc.1991-10-02
ADVANCE SUTURE NONABSORBABLE NYLON SUTURE (K903177)Advance Suture, Inc.1991-06-28
IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES (K905286)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* (K904931)United States Surgical, A Division of Tyco Healthc1991-01-29
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP (K905379)United States Surgical, A Division of Tyco Healthc1991-01-17
SUPRAMID EXTRA SUTURES (K904052)S. Jackson, Inc.1990-10-25
STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE (K903029)Look, Inc.1990-10-25
NONABSORBABLE NYLON SURGICAL SUTURE* (K900531)United States Surgical, A Division of Tyco Healthc1990-07-05

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Every clearance here is in the API, with alerts when new ones post.