Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
General, Plastic Surgery · 21 CFR 878.5035
Recent MDR events
27 adverse event reports on file
- MONOTEXMay 28, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00023
- MONOTEXMay 15, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00022
- MONOTEXApr 28, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00019
- MAXIMA PTFEApr 27, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00013
- MAXIMA PTFEApr 27, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00014
- MAXIMA PTFEApr 27, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00015
- MAXIMA PTFEApr 27, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00016
- MAXIMA PTFEApr 27, 2026MalfunctionRiverpoint Medical Llc3009681798-2026-00017
- CYTOSURGSep 19, 2025MalfunctionRiverpoint Medical Llc3006981798-2025-00036
- MICROSUTUREApr 22, 2024MalfunctionRiverpoint Medical Llc3006981798-2024-00031
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
42 firms currently registered for this product code
Isomedix Operations, Inc.
Temecula, CA, US
Osteogenics Biomedical, Inc.
LUBBOCK, TX, US
Pronorth Medical
ABBOTSFORD British Columbia, CA
Isomedix Operations Inc.
S Plainfield, NJ, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Steritec Services, Llc
ATHENS, TX, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Lsi Solutions Inc.
VICTOR, NY, US
Durastat
Austin, TX, US
Surgical Specialties Mexico S De Rl De Cv
Tijuana Baja California, MX
Demetech Corp.
Miami Lakes, FL, US
Camark Sa
Axioupoli Kentriki Makedonia, GR
Golnit Ltd
Kiev Kyyiv, Misto, UA
Sweden & Martina Inc
Naperville, IL, US
Antarma Llc
New York, NY, US
Kollsut International Inc
North Miami Beach, FL, US
Cypris Medical, Inc.
Evanston, IL, US
Salvin Dental Specialties, Llc
CHARLOTTE, NC, US
J Sterling Industries Llc
Kalamazoo, MI, US
Purgo Biologics Inc.
Seongnam-si Gyeonggi, KR
Origami Surgical Inc.
Dover, MA, US
Neoss Ab
Goteborg Vastra Gotaland, SE
510(k) clearances
17 clearances for this product code
- Durastat, LLCNov 9, 2023
K231277 · TissueStat
- Antarma, LLC Dba Golnit SuturesSep 4, 2019
K192088 · GOLNIT Non-aborbable PTFE Surgical Suture
- Purgo Biologics, Inc.Jul 16, 2019
K180992 · Biotex
- Origami SurgicalJul 12, 2019
K191317 · StitchKit
- Demetech CorporationOct 11, 2018
K181578 · DemeTECH PTFE Nonabsorbable Surgical Suture
- Omnia SpaApr 6, 2018
K180630 · PTFE SURGICAL SUTURE
- Cp Medical, Inc.Mar 26, 2018
K173922 · C-PTFETM Surgical Suture
- Dura Tap, LLCFeb 8, 2018
K173335 · Gazelle PTFE and Suture Delivery Device