DeviceClearance

Product code NJC— General, Plastic Surgery

TI CLIP APPLIER

Classification name
Clip, Vas Deferens
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation.”

— U.S. Food and Drug Administration, device classification record for product code NJC under 21 CFR 878.4300, via openFDA

Market context for product code NJC

FDA has cleared 2 devices under product code NJC between 2002 and 2004, 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.

Clearances per year

Top applicants under product code NJC

Recent clearances under product code NJC

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