NWJ — Suture, Recombinant Technology Class II
FDA product code NWJ covers "Suture, Recombinant Technology", a Class II medical device regulated under 21 CFR 878.4494. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NWJ
- Device Class
- Class II
- Regulation Number
- 878.4494
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211307 | tepha | GalaSTITCH Absorbable Monofilament Suture | May 27, 2021 |
| K132348 | tepha | TEPHAFLEX BRAIDED SUTURE | September 5, 2013 |
| K130422 | tornier | PHANTOM FIBER BIOFIBER SUTURE | April 4, 2013 |
| K122487 | tornier | BIOFIBER SYTURE | September 17, 2012 |
| K100876 | aesculap | AESCULAP MONOMAX ABSORBABLE SUTURE | July 14, 2010 |
| K082178 | tepha | TEPHAFLEX ABSORBABLE SUTURE | October 30, 2008 |
| K081099 | tepha | TEPHAFLEX ABSORBABLE SUTURE | July 15, 2008 |
| K072470 | entrigue surgical | BIOELAST 5-0 SUTURE, MODEL 500100 | November 16, 2007 |
| DEN060003 | tepha | TEPHAFLEX ABSORBABLE SUTURE | February 8, 2007 |