ClearanceBrief
Panels › General, Plastic Surgery › Product code NBY · Class 2

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Regulation 878.5035

0510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in NBY

Company510(k)sRecalls
Antarma Dba Golnit Sutures20
Omnia Spa20
Origami Surgical20
Osteogenics Biomedical, Inc.20
Cp Medical, Inc.10
Demetech Corporation10
Dura Tap, LLC10
Durastat, LLC10
Foosin Medical Supplies Inc., Ltd.10
Lsi Solutions10
Decided510(k)Device and applicantCode
Nov 9, 2023K231277TissueStat
Durastat, LLC
NBY
Sep 4, 2019K192088GOLNIT Non-aborbable PTFE Surgical Suture
Antarma, LLC Dba Golnit Sutures
NBY
Jul 16, 2019K180992Biotex
Purgo Biologics, Inc., KR
NBY
Jul 12, 2019K191317StitchKit
Origami Surgical
NBY
Oct 11, 2018K181578DemeTECH PTFE Nonabsorbable Surgical Suture
Demetech Corporation
NBY
Apr 6, 2018K180630PTFE SURGICAL SUTURE
Omnia Spa, IT
NBY
Mar 26, 2018K173922C-PTFETM Surgical Suture
Cp Medical, Inc.
NBY
Feb 8, 2018K173335Gazelle PTFE and Suture Delivery Device
Dura Tap, LLC
NBY
Jul 31, 2017K170842WEGO-PTFE
Foosin Medical Supplies Inc., Ltd., CN
NBY
Jun 21, 2017K163049GOLNIT Non-Absorbable PTFE Surgical Suture
Antarma Dba Golnit Sutures
NBY
Jun 2, 2017K163639LS-5 ePTFE Suture
Lsi Solutions
NBY
Jul 13, 2016K160744LOOK PTFE Suture
Surgical Specialties Corporation, MX
NBY
Mar 26, 2014K140415MONOTEX
Riverpoint Medical
NBY
Feb 12, 2014K132464PTFE SURGICAL SUTURE
Omnia Spa, IT
NBY
Sep 5, 2013K123811STITCHKIT
Origami Surgical, LLC
NBY
Oct 31, 2007K072076CYTOPLAST PTFE SUTURE
Osteogenics Biomedical, Inc.
NBY
Nov 24, 2000K003028CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
Osteogenics Biomedical, Inc.
NBY

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