Atlas FDA

GAS

17 FDA 510(k) clearances · Product code

83 daysmedian time to decision
397 days90th percentile
17clearances measured

FDA profile

Official device name
Suture, Nonabsorbable, Synthetic, Polyester
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5000
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2009: 56 · 2010: 24 · 2011: 25 · 2012: 73 · 2013: 21 · 2014: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene (K203120)Lsi Solutions, Inc.2020-11-24
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (K203081)Lsi Solutions2020-11-24
ARTHREX BIOWIRE (K091018)Arthrex, Inc.2010-07-30
MR-III (K002261)Smith & Nephew, Inc.2000-10-23
SUTURE CORD (K953128)Phoenix Biomedical Corp.1996-02-09
BRAIDED POLYESTER SUTURE MATERIAL (K923161)Mitek Surgical Products, Inc.1992-12-30
PETERS CARDIOFLON(TM) SUTURE (K913101)Promedica Products, Inc.1992-08-12
MITEK QUICKANCHOR(TM), MODIFICATION (K915089)Mitek Surgical Products, Inc.1992-02-03
MITEK SNAP PAK(TM), MODIFICATION (K915081)Mitek Surgical Products, Inc.1992-01-31
ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (K903175)Advance Suture, Inc.1991-07-26
IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (K905285)Internacional Farmaceutica, S.A. DE C.V.1991-02-11
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE (K905440)United States Surgical, A Division of Tyco Healthc1991-01-31
LU-TEX II (K904535)Lukens Medical Corp.1991-01-30
QUICKANCHOR (TM) (K904436)Mitek Surgical Products, Inc.1990-12-11
DACRON R SURGICAL SUTURES (K904263)Sharppoint, Inc.1990-10-16
POLYVIOLENE(TM) SUTURE (K904054)Look, Inc.1990-10-03
NONABSORBABLE DACRON SURGICAL SUTURE* (K902873)United States Surgical, A Division of Tyco Healthc1990-09-27

Track GAS automatically

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