Last synced on 27 January 2023 at 11:04 pm

Staple, Implantable

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4750
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4750 Implantable staple

§ 878.4750 Implantable staple.

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

(b) Classification. Class II.

Staple, Implantable

Page Type
Product Code
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4750
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4750 Implantable staple

§ 878.4750 Implantable staple.

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

(b) Classification. Class II.