Atlas FDA

NBY

17 FDA 510(k) clearances · Product code

118 daysmedian time to decision
268 days90th percentile
17clearances measured

FDA profile

Official device name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5035
Medical specialty
General, Plastic Surgery
Flags
Implant
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RecordFirmDate
TissueStat (K231277)Durastat, LLC2023-11-09
GOLNIT Non-aborbable PTFE Surgical Suture (K192088)Antarma, LLC Dba Golnit Sutures2019-09-04
Biotex (K180992)Purgo Biologics, Inc.2019-07-16
StitchKit (K191317)Origami Surgical2019-07-12
DemeTECH PTFE Nonabsorbable Surgical Suture (K181578)Demetech Corporation2018-10-11
PTFE SURGICAL SUTURE (K180630)Omnia Spa2018-04-06
C-PTFETM Surgical Suture (K173922)Cp Medical, Inc.2018-03-26
Gazelle PTFE and Suture Delivery Device (K173335)Dura Tap, LLC2018-02-08
WEGO-PTFE (K170842)Foosin Medical Supplies Inc., Ltd.2017-07-31
GOLNIT Non-Absorbable PTFE Surgical Suture (K163049)Antarma Dba Golnit Sutures2017-06-21
LS-5 ePTFE Suture (K163639)Lsi Solutions2017-06-02
LOOK PTFE Suture (K160744)Surgical Specialties Corporation2016-07-13
MONOTEX (K140415)Riverpoint Medical2014-03-26
PTFE SURGICAL SUTURE (K132464)Omnia Spa2014-02-12
STITCHKIT (K123811)Origami Surgical, LLC2013-09-05
CYTOPLAST PTFE SUTURE (K072076)Osteogenics Biomedical, Inc.2007-10-31
CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC (K003028)Osteogenics Biomedical, Inc.2000-11-24

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