Atlas FDA

GAP

41 FDA 510(k) clearances · Product code

84 daysmedian time to decision
324 days90th percentile
41clearances measured

FDA profile

Official device name
Suture, Nonabsorbable, Silk
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5030
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 437 · 2022: 419 · 2023: 404 · 2024: 455 · 2025: 488 · 2026: 292
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
Sofsilk™ Coated Braided Silk Suture (K241486)Covidien2024-12-03
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (K222944)Safepath Medical, Inc.2024-10-18
Non absorbable Surgical Silk Suture (K232355)Shandong Haidike Medical Product Co., Ltd.2024-01-16
Surgical Sutures with or without Needle (K221767)Huaian Seamen Medical Technology Co., Ltd.2023-07-31
SafePath Suturing System (K180701)Safepath Medical, Inc.2018-06-25
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K172149)M/s. Meril Endo Surgery Private Limited.2017-10-20
SILK Surgical Suture (K162396)Teleflexmedical, Inc.2016-11-23
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K160623)M/s. Meril Endo Surgery Private Limited.2016-05-31
WG-SURGICAL SUTURES WITH NEEDLE (K080684)Foosin Medical Supplies, Inc.2008-06-09
NON-ABSORBABLE SILK SUTURE (K071111)Arrow Intl., Inc.2007-07-17
MANI NEEDLE & SUTURE PACK (SILK) (K053638)Mani, Inc.2006-05-19
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE (K041514)Sutures India Private Limited2005-06-03
UNISILK (K042282)United Medical Industries Co. , Ltd.2004-12-01
SILK SUTURES (K024091)Aurolab2003-02-28
DEMETECH SILK NONABSORBABLE SUTURE (K023029)Demetech Corp.2002-11-25
SERRALSILK (K020901)Serral, S.A. DE C.V.2002-04-26
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP (K012124)Johnson & Johnson Medical (China) , Ltd.2001-09-19
GRAMS SILK NONABSORBABLE SUTURE (K003001)Gramsmed, LLC2000-12-15
SILK, NONABSORBABLE, SURGICAL SUTURES, USP (K001184)Cp Medical2000-06-23
SILK NONABSORBABLE SURGICAL SUTURES, USP (K000541)Arc Medical Supplies (Beijing) Co, Ltd.2000-04-28
SUTRASILK SILK SUTURE (K994177)Visionary Medical Supplies, Inc.2000-02-08
SILK (K993999)Trading Consultants and Distributors Intl., Inc.2000-02-04
SILK SUTURE (K982853)Davis & Geck, Inc.1999-04-30
SILKAM NONABSORBABLE SILK SURGICAL SUTURE (K990089)Aesculap, Inc.1999-03-15
SOFSILK SUTURE (K981128)United States Surgical, A Division of Tyco Healthc1998-05-11
SOFSILK SUTURE (K980124)United States Surgical, A Division of Tyco Healthc1998-03-27
SOFSILK (K964581)United States Surgical, A Division of Tyco Healthc1997-01-16
SILK NONABSORBABLE SURGICAL SUTURES USP (K960328)R. K. Medical L. L. C.1996-03-04
SURGISILK (K943627)Sutures , Ltd.1994-12-05
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (K930739)Deknatel, Inc.1994-07-26
VISITEC PRECISE-POINT (K942234)Visitec Co.1994-07-12
SUTURE NON-ABSORBABLE SILK (K931913)Surgimetrics International, Ltd.1994-03-03
SUTURE NONABSORBABLE - SILK (K930826)Surgical Specialties, Inc.1994-01-07
SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES (K930825)Surgical Specialties, Inc.1994-01-07
ADVANCE SUTURE NONABSORBABLE SILK SUTURE (K905454)Advance Suture, Inc.1991-06-28
IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES (K905287)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
NONABSORBABLE SILK SURGICAL SUTURE (K904478)United States Surgical, A Division of Tyco Healthc1990-11-14
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE) (K904891)United States Surgical, A Division of Tyco Healthc1990-11-14
AIRWAY PRESSURE MONITOR (K761199)Draeger Medical, Inc.1977-02-28
RETRACTOR, GERBODE STERNAL (K760650)Dilling Co.1976-09-21
NEEDLES AND SUTURES, SILK & NYLON (K760158)Alcon Laboratories1976-08-19

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