Product code NWJ— General, Plastic Surgery
TEPHAFLEX ABSORBABLE SUTURE
- Classification name
- Suture, Recombinant Technology
- Device class
- Class 2
- Regulation
- 21 CFR 878.4494
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.”
Market context for product code NWJ
FDA has cleared devices under product code NWJ between 2007 and 2021, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2013
- 2012
- 2010
- 2008
- 2007
Top applicants under product code NWJ
Recent clearances under product code NWJ
- K211307 — GalaSTITCH Absorbable Monofilament Suture
- K132348 — TEPHAFLEX BRAIDED SUTURE
- K130422 — PHANTOM FIBER BIOFIBER SUTURE
- K122487 — BIOFIBER SYTURE
- K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE
- K082178 — TEPHAFLEX ABSORBABLE SUTURE
- K081099 — TEPHAFLEX ABSORBABLE SUTURE
- K072470 — BIOELAST 5-0 SUTURE, MODEL 500100
- DEN060003 — TEPHAFLEX ABSORBABLE SUTURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.