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Mesh, Surgical, For Stress Urinary Incontinence, Male

Page Type
Product Code
Definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Physical State
biologic (e.g., collagen) and/or synthetic (e.g, metallic or polymeric) woven fabric of varying design and material properties
Technical Method
permanently implantable sling placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.), device applies pressure to the urethra to prevent urine leakage
Target Area
bladder, urethra
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
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, For Stress Urinary Incontinence, Male

Page Type
Product Code
Definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Physical State
biologic (e.g., collagen) and/or synthetic (e.g, metallic or polymeric) woven fabric of varying design and material properties
Technical Method
permanently implantable sling placed under the urethra; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.), device applies pressure to the urethra to prevent urine leakage
Target Area
bladder, urethra
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
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.