FDA Product Code
FDA Product Code NBY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5035
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231277 | TissueStat | Durastat, LLC | 2023-11-09 | Traditional | PDF ↗ |
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | 2019-09-04 | Special | PDF ↗ |
| K180992 | Biotex | Purgo Biologics, Inc. | 2019-07-16 | Abbreviated | PDF ↗ |
| K191317 | StitchKit | Origami Surgical | 2019-07-12 | Traditional | PDF ↗ |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corporation | 2018-10-11 | Traditional | PDF ↗ |
| K180630 | PTFE SURGICAL SUTURE | Omnia Spa | 2018-04-06 | Special | PDF ↗ |
| K173922 | C-PTFETM Surgical Suture | Cp Medical, Inc. | 2018-03-26 | Traditional | PDF ↗ |
| K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | 2018-02-08 | Abbreviated | PDF ↗ |
| K170842 | WEGO-PTFE | Foosin Medical Supplies Inc., Ltd. | 2017-07-31 | Traditional | PDF ↗ |
| K163049 | GOLNIT Non-Absorbable PTFE Surgical Suture | Antarma Dba Golnit Sutures | 2017-06-21 | Traditional | PDF ↗ |
| K163639 | LS-5 ePTFE Suture | Lsi Solutions | 2017-06-02 | Traditional | PDF ↗ |
| K160744 | LOOK PTFE Suture | Surgical Specialties Corporation | 2016-07-13 | Traditional | PDF ↗ |
| K140415 | MONOTEX | Riverpoint Medical | 2014-03-26 | Abbreviated | PDF ↗ |
| K132464 | PTFE SURGICAL SUTURE | Omnia Spa | 2014-02-12 | Traditional | PDF ↗ |
| K123811 | STITCHKIT | Origami Surgical, LLC | 2013-09-05 | Traditional | PDF ↗ |
| K072076 | CYTOPLAST PTFE SUTURE | Osteogenics Biomedical, Inc. | 2007-10-31 | Abbreviated | PDF ↗ |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Osteogenics Biomedical, Inc. | 2000-11-24 | Traditional | PDF ↗ |
Product code NBY · Class II · General, Plastic Surgery. Data: openFDA.