Last synced on 2 December 2022 at 11:04 pm

Clip, Vas Deferens

Page Type
Product Code
Definition
This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4300 Implantable clip

§ 878.4300 Implantable clip.

(a) Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

(b) Classification. Class II.

Clip, Vas Deferens

Page Type
Product Code
Definition
This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4300 Implantable clip

§ 878.4300 Implantable clip.

(a) Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

(b) Classification. Class II.