NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Class II
FDA product code NBY covers "Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene", a Class II medical device regulated under 21 CFR 878.5035. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 17 recent 510(k) clearances have been granted under this product code.
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 |