DeviceClearance

Product code NJU— General, Plastic Surgery

COALESCENT U-CLIP- AND ACCESSORIES

Classification name
Suture, Nonabsorbable, Nitinol
Device class
Class 2
Regulation
21 CFR 878.4495
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“Soft tissue approximation.”

— U.S. Food and Drug Administration, device classification record for product code NJU under 21 CFR 878.4495, via openFDA

Market context for product code NJU

FDA has cleared 2 devices under product code NJU, all in 2002, filed by 2 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.

Top applicants under product code NJU

Recent clearances under product code NJU

Data sourced from openFDA. This site is unofficial and independent of the FDA.