FDA Product Code
FDA Product Code NWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4494
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211307 | GalaSTITCH Absorbable Monofilament Suture | Tepha, Inc. | 2021-05-27 | Special | PDF ↗ |
| K132348 | TEPHAFLEX BRAIDED SUTURE | Tepha, Inc. | 2013-09-05 | Traditional | PDF ↗ |
| K130422 | PHANTOM FIBER BIOFIBER SUTURE | Tornier, Inc. | 2013-04-04 | Special | PDF ↗ |
| K122487 | BIOFIBER SYTURE | Tornier, Inc. | 2012-09-17 | Traditional | PDF ↗ |
| K100876 | AESCULAP MONOMAX ABSORBABLE SUTURE | Aesculap, Inc. | 2010-07-14 | Traditional | PDF ↗ |
| K082178 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | 2008-10-30 | Traditional | PDF ↗ |
| K081099 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | 2008-07-15 | Traditional | PDF ↗ |
| K072470 | BIOELAST 5-0 SUTURE, MODEL 500100 | Entrigue Surgical, Inc. | 2007-11-16 | Traditional | PDF ↗ |
| DEN060003 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | 2007-02-08 | Post-NSE | — |
Product code NWJ · Class II · General, Plastic Surgery. Data: openFDA.