Last synced on 2 December 2022 at 11:04 pm

Mesh, Surgical, Deployer

Page Type
Product Code
Definition
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Physical State
manual laparoscopic surgical instrument ;operation handle and deployment section.
Technical Method
intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.
Target Area
abdominal cavity
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
No
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, Deployer

Page Type
Product Code
Definition
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Physical State
manual laparoscopic surgical instrument ;operation handle and deployment section.
Technical Method
intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.
Target Area
abdominal cavity
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
No
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.