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K Number
K982403
Device Name
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
1998-09-22

(74 days)

Product Code
PAG
Regulation Number
878.3300
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.

Device Description

Brennen Biosynthetic Surgical Mesh Matrix

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a surgical mesh, focusing on regulatory aspects, indications for use, and legal compliance. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

§ 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.