NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Class II
FDA Device Classification
Classification Details
- Product Code
- NBY
- Device Class
- Class II
- Regulation Number
- 878.5035
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231277 | durastat | TissueStat | November 9, 2023 |
| K192088 | antarma, llc dba golnit sutures | GOLNIT Non-aborbable PTFE Surgical Suture | September 4, 2019 |
| K180992 | purgo biologics | Biotex | July 16, 2019 |
| K191317 | origami surgical | StitchKit | July 12, 2019 |
| K181578 | demetech corporation | DemeTECH PTFE Nonabsorbable Surgical Suture | October 11, 2018 |
| K180630 | omnia | PTFE SURGICAL SUTURE | April 6, 2018 |
| K173922 | cp medical | C-PTFETM Surgical Suture | March 26, 2018 |
| K173335 | dura tap | Gazelle PTFE and Suture Delivery Device | February 8, 2018 |
| K170842 | foosin medical supplies inc | WEGO-PTFE | July 31, 2017 |
| K163049 | antarma dba golnit sutures | GOLNIT Non-Absorbable PTFE Surgical Suture | June 21, 2017 |
| K163639 | lsi solutions | LS-5 ePTFE Suture | June 2, 2017 |
| K160744 | surgical specialties corporation | LOOK PTFE Suture | July 13, 2016 |
| K140415 | riverpoint medical | MONOTEX | March 26, 2014 |
| K132464 | omnia | PTFE SURGICAL SUTURE | February 12, 2014 |
| K123811 | origami surgical | STITCHKIT | September 5, 2013 |
| K072076 | osteogenics biomedical | CYTOPLAST PTFE SUTURE | October 31, 2007 |
| K003028 | osteogenics biomedical | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | November 24, 2000 |