NWJ
9 FDA 510(k) clearances · Product code
73 daysmedian time to decision
272 days90th percentile
9clearances measured
FDA profile
- Official device name
- Suture, Recombinant Technology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4494
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
- Adverse events (MAUDE)
- 2014: 12 · 2015: 8 · 2016: 13 · 2017: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GalaSTITCH Absorbable Monofilament Suture (K211307) | Tepha, Inc. | 2021-05-27 |
| TEPHAFLEX BRAIDED SUTURE (K132348) | Tepha, Inc. | 2013-09-05 |
| PHANTOM FIBER BIOFIBER SUTURE (K130422) | Tornier, Inc. | 2013-04-04 |
| BIOFIBER SYTURE (K122487) | Tornier, Inc. | 2012-09-17 |
| AESCULAP MONOMAX ABSORBABLE SUTURE (K100876) | Aesculap, Inc. | 2010-07-14 |
| TEPHAFLEX ABSORBABLE SUTURE (K082178) | Tepha, Inc. | 2008-10-30 |
| TEPHAFLEX ABSORBABLE SUTURE (K081099) | Tepha, Inc. | 2008-07-15 |
| BIOELAST 5-0 SUTURE, MODEL 500100 (K072470) | Entrigue Surgical, Inc. | 2007-11-16 |
| TEPHAFLEX ABSORBABLE SUTURE (DEN060003) | Tepha, Inc. | 2007-02-08 |
Track NWJ automatically
Every clearance here is in the API, with alerts when new ones post.