Last synced on 25 November 2022 at 11:04 pm

Staple, Implantable, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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
No
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, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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
No
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.