Atlas FDA

GAQ

32 FDA 510(k) clearances · Product code

139 daysmedian time to decision
305 days90th percentile
32clearances measured

FDA profile

Official device name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4495
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 39 · 2022: 70 · 2023: 100 · 2024: 176 · 2025: 86 · 2026: 69
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
CoNextions TR Tendon Repair System (K203855)Conextions Medical2022-04-22
Wego-Stainless Steel (K193209)Foosin Medical Supplies Inc., Ltd.2020-02-19
MERISTEEL (K172146)M/s. Meril Endo Surgery Private Limited.2018-02-01
Surgical Stainless Steel Suture, Stainless Steel Suture (K170767)ETHICON, Inc.2017-11-01
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (K141007)Demetech Corp.2014-09-25
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (K140127)Pontis Orthopaedics, LLC2014-05-28
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060)Core Essence Orthopaedics, LLC2008-12-24
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (K082828)Suturtek Incorporated2008-10-14
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (K063603)Suturtek Incorporated2007-02-07
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (K042606)Synthes (Usa)2005-05-27
SYNTHES (USA) TITANIUM WIRE (K041333)Synthes (Usa)2004-08-27
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE (K032468)Suturtek Incorporated2003-09-23
TENO FIX (K023594)Ortheon Medical, LLC2003-05-15
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (K030351)Cp Medical2003-03-28
STEELEX STERNUM SET (K023411)Aesculap, Inc.2002-12-19
MANUAL TOUCHE SYSTEM (K022777)Onux Medical, Inc.2002-11-19
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) (K013059)Stony Brook Surgical Innovations, Inc.2001-10-22
ACIER SUTURES (K991073)Cardio Thoracic Systems1999-07-30
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP (K984151)Mill Pond, Inc.1999-04-28
STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) (K955723)Davis & Geck, Inc.1996-02-27
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK (K946173)ETHICON, Inc.1995-01-09
SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL (K930740)Deknatel, Inc.1994-07-26
STAINLESS STEEL SUTURE (K931915)Surgimetrics International, Ltd.1994-03-03
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE (K931271)ETHICON, Inc.1994-01-07
LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE (K933686)Look, Inc.1993-12-23
FLEXON AND STAINLESS STEEL SUTURES (K930992)American Cyanamid Co.1993-12-17
LUKENS STAINLESS STEEL SURGICAL SUTURE (K930940)Lukens Medical Corp.1993-12-17
STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT (K913185)Internacional Farmaceutica, S.A. DE C.V.1991-12-04
LEG URINAL (K913155)Ezmt Valve Co., Inc.1991-09-16
PTI STERNAL CLOSURE WIRE SUTURE (K910067)Pioneering Technologies, Inc.1991-05-06
STAINLESS 22-13-5 SUTURE WIRE (K873645)Zimmer, Inc.1987-11-17
SURGISTEEL (K865038)Sutures , Ltd.1987-06-30

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