Product Code: NJC FDA class 2 21 CFR 878.4300

Clip, Vas Deferens

General, Plastic Surgery

The Vas Deferens Clip is an implantable surgical clip intended to ligate the vas deferens as part of a vasectomy procedure for male sterilization. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJC and regulation 21 CFR 878.4300 in the General and Plastic Surgery specialty. The device is flagged as an implant but is not life-sustaining.

510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
2

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Basic Information

Product Code
NJC
Device Class
FDA class 2
Regulation Number
878.4300
Medical Specialty
General, Plastic Surgery
Review Panel
SU
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

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

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K034029 TI CLIP APPLIER
K021745 VASCLIP