NJC — Clip, Vas Deferens Class II

FDA Device Classification

FDA product code NJC covers "Clip, Vas Deferens", a Class II medical device regulated under 21 CFR 878.4300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NJC
Device Class
Class II
Regulation Number
878.4300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K034029gyrxTI CLIP APPLIERMarch 5, 2004
K021745vmbcVASCLIPAugust 20, 2002