NWJ · Class II · 21 CFR 878.4494

FDA Product Code NWJ: Suture, Recombinant Technology

Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation.

Leading manufacturers include Tepha, Inc., Tornier, Inc. and Entrigue Surgical, Inc..

9
Total
8
Cleared
86d
Avg days
2007
Since

FDA 510(k) Cleared Suture, Recombinant Technology Devices (Product Code NWJ)

9 devices
1–9 of 9
Cleared May 27, 2021
GalaSTITCH Absorbable Monofilament Suture
K211307
Tepha, Inc.
General & Plastic Surgery · 28d
Cleared Sep 05, 2013
TEPHAFLEX BRAIDED SUTURE
K132348
Tepha, Inc.
General & Plastic Surgery · 38d
Cleared Apr 04, 2013
PHANTOM FIBER BIOFIBER SUTURE
K130422
Tornier, Inc.
General & Plastic Surgery · 43d
Cleared Sep 17, 2012
BIOFIBER SYTURE
K122487
Tornier, Inc.
General & Plastic Surgery · 33d
Cleared Jul 14, 2010
AESCULAP MONOMAX ABSORBABLE SUTURE
K100876
Aesculap, Inc.
General & Plastic Surgery · 106d
Cleared Oct 30, 2008
TEPHAFLEX ABSORBABLE SUTURE
K082178
Tepha, Inc.
General & Plastic Surgery · 90d
Cleared Jul 15, 2008
TEPHAFLEX ABSORBABLE SUTURE
K081099
Tepha, Inc.
General & Plastic Surgery · 89d
Cleared Nov 16, 2007
BIOELAST 5-0 SUTURE, MODEL 500100
K072470
Entrigue Surgical, Inc.
General & Plastic Surgery · 73d
Not Cleared Feb 08, 2007
TEPHAFLEX ABSORBABLE SUTURE
DEN060003
Tepha, Inc.
General & Plastic Surgery · 272d

About Product Code NWJ - Regulatory Context