Last synced on 2 December 2022 at 11:04 pm

Mesh, Surgical, Collagen, Staple Line Reinforcement

Page Type
Product Code
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Physical State
A collagen mesh; either square, rectangular, round or of various other shapes
Technical Method
A collagen mesh that reinforces soft tissue
Target Area
Areas in need of sutures
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3300 Surgical mesh

§ 878.3300 Surgical mesh.

(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b) Classification. Class II.

Mesh, Surgical, Collagen, Staple Line Reinforcement

Page Type
Product Code
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Physical State
A collagen mesh; either square, rectangular, round or of various other shapes
Technical Method
A collagen mesh that reinforces soft tissue
Target Area
Areas in need of sutures
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3300 Surgical mesh

§ 878.3300 Surgical mesh.

(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b) Classification. Class II.