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Mesh, Surgical, Deployment Balloon

Page Type
Product Code
Definition
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Physical State
The device is comprised of three main components: an inflatable spreading balloon, an adaptor, and an inflation unit/pump.
Technical Method
The device is reversibly attached to soft tissue prosthetics, such as surgical mesh, through the use of connectors, before being rolled for insertion into the body. Once located in the abdominal cavity, the device is spread at the desired location by inflating it using an external inflation pump.
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, Deployment Balloon

Page Type
Product Code
Definition
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Physical State
The device is comprised of three main components: an inflatable spreading balloon, an adaptor, and an inflation unit/pump.
Technical Method
The device is reversibly attached to soft tissue prosthetics, such as surgical mesh, through the use of connectors, before being rolled for insertion into the body. Once located in the abdominal cavity, the device is spread at the desired location by inflating it using an external inflation pump.
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.