NBY · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
General, Plastic Surgery · 21 CFR 878.5035 · Class 2
Overview
| Product Code | NBY |
|---|---|
| Device Name | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Regulation | 21 CFR 878.5035 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231277 | TissueStat | Durastat, LLC | Nov 9, 2023 | SESE |
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | Sep 4, 2019 | SESE |
| K180992 | Biotex | Purgo Biologics, Inc. | Jul 16, 2019 | SESE |
| K191317 | StitchKit | Origami Surgical | Jul 12, 2019 | SESE |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corporation | Oct 11, 2018 | SESE |
| K180630 | PTFE SURGICAL SUTURE | Omnia Spa | Apr 6, 2018 | SESE |
| K173922 | C-PTFETM Surgical Suture | Cp Medical, Inc. | Mar 26, 2018 | SESE |
| K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | Feb 8, 2018 | SESE |
| K170842 | WEGO-PTFE | Foosin Medical Supplies Inc., Ltd. | Jul 31, 2017 | SESE |
| K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | Antarma Dba Golnit Sutures | Jun 21, 2017 | SESE |
| K163639 | LS-5 ePTFE Suture | Lsi Solutions | Jun 2, 2017 | SESE |
| K160744 | LOOK PTFE Suture | Surgical Specialties Corporation | Jul 13, 2016 | SESE |
| K140415 | MONOTEX | Riverpoint Medical | Mar 26, 2014 | SESE |
| K132464 | PTFE SURGICAL SUTURE | Omnia Spa | Feb 12, 2014 | SESE |
| K123811 | STITCHKIT | Origami Surgical, LLC | Sep 5, 2013 | SESE |
| K072076 | CYTOPLAST PTFE SUTURE | Osteogenics Biomedical, Inc. | Oct 31, 2007 | SESE |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Osteogenics Biomedical, Inc. | Nov 24, 2000 | SESE |
Top Applicants
- Omnia Spa — 2 clearances
- Osteogenics Biomedical, Inc. — 2 clearances
- Antarma Dba Golnit Sutures — 1 clearance
- Antarma, LLC Dba Golnit Sutures — 1 clearance
- Cp Medical, Inc. — 1 clearance
