Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
The Nonabsorbable Expanded Polytetrafluoroethylene (ePTFE) Surgical Suture is a permanent synthetic suture made from expanded PTFE material, used to approximate and secure tissue during cardiovascular, general, and plastic surgery procedures. ePTFE sutures are valued for their smoothness, low friction, and excellent biocompatibility. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 878.5035 (General and Plastic Surgery specialty). This device carries the implant flag.
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Basic Information
- Product Code
- NBY
- Device Class
- FDA class 2
- Regulation Number
- 878.5035
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231277 | TissueStat | Nov 09, 2023 | Substantially Equivalent | Durastat, LLC |
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Sep 04, 2019 | Substantially Equivalent | Antarma, LLC Dba Golnit Sutures |
| K180992 | Biotex | Jul 16, 2019 | Substantially Equivalent | Purgo Biologics, Inc. |
| K191317 | StitchKit | Jul 12, 2019 | Substantially Equivalent | Origami Surgical |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Oct 11, 2018 | Substantially Equivalent | Demetech Corporation |
| K180630 | PTFE SURGICAL SUTURE | Apr 06, 2018 | Substantially Equivalent | Omnia Spa |
| K173922 | C-PTFETM Surgical Suture | Mar 26, 2018 | Substantially Equivalent | Cp Medical, Inc. |
| K173335 | Gazelle PTFE and Suture Delivery Device | Feb 08, 2018 | Substantially Equivalent | Dura Tap, LLC |
| K170842 | WEGO-PTFE | Jul 31, 2017 | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. |
| K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | Jun 21, 2017 | Substantially Equivalent | Antarma Dba Golnit Sutures |
| K163639 | LS-5 ePTFE Suture | Jun 02, 2017 | Substantially Equivalent | Lsi Solutions |
| K160744 | LOOK PTFE Suture | Jul 13, 2016 | Substantially Equivalent | Surgical Specialties Corporation |
| K140415 | MONOTEX | Mar 26, 2014 | Substantially Equivalent | Riverpoint Medical |
| K132464 | PTFE SURGICAL SUTURE | Feb 12, 2014 | Substantially Equivalent | Omnia Spa |
| K123811 | STITCHKIT | Sep 05, 2013 | Substantially Equivalent | Origami Surgical, LLC |
| K072076 | CYTOPLAST PTFE SUTURE | Oct 31, 2007 | Substantially Equivalent | Osteogenics Biomedical, Inc. |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Nov 24, 2000 | Substantially Equivalent | Osteogenics Biomedical, Inc. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.