Panels › General, Plastic Surgery › Product code NWJ · Class 2
Suture, Recombinant Technology
Regulation 878.4494
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NWJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Tepha, Inc. | 5 | 0 |
| Tornier, Inc. | 2 | 1 |
| Aesculap, Inc. | 1 | 0 |
| Entrigue Surgical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2021 | K211307 | GalaSTITCH Absorbable Monofilament Suture Tepha, Inc. | NWJ |
| Sep 5, 2013 | K132348 | TEPHAFLEX BRAIDED SUTURE Tepha, Inc. | NWJ |
| Apr 4, 2013 | K130422 | PHANTOM FIBER BIOFIBER SUTURE Tornier, Inc. | NWJ |
| Sep 17, 2012 | K122487 | BIOFIBER SYTURE Tornier, Inc. | NWJ |
| Jul 14, 2010 | K100876 | AESCULAP MONOMAX ABSORBABLE SUTURE Aesculap, Inc. | NWJ |
| Oct 30, 2008 | K082178 | TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. | NWJ |
| Jul 15, 2008 | K081099 | TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. | NWJ |
| Nov 16, 2007 | K072470 | BIOELAST 5-0 SUTURE, MODEL 500100 Entrigue Surgical, Inc. | NWJ |
| Feb 8, 2007 | DEN060003 | TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. | NWJ |
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