NJU · Class II · 21 CFR 878.4495

FDA Product Code NJU: Suture, Nonabsorbable, Nitinol

Soft Tissue Approximation.

Leading manufacturers include Coalescent Surgical and Onux Medical, Inc..

2
Total
2
Cleared
85d
Avg days
2002
Since

FDA 510(k) Cleared Suture, Nonabsorbable, Nitinol Devices (Product Code NJU)

2 devices
1–2 of 2
Cleared Dec 27, 2002
NON-BIOABSORBABLE STAPLE
K023372
Onux Medical, Inc.
General & Plastic Surgery · 80d
Cleared Dec 18, 2002
COALESCENT U-CLIP- AND ACCESSORIES
K023125
Coalescent Surgical
General & Plastic Surgery · 90d

About Product Code NJU - Regulatory Context