# K982403: Brennen Biosynthetic Surgical Mesh Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, Inc.
- Decided: Sep 22, 1998 after 74 days
- Product code: PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993459: Modification to Brennen Biosynthetic Surgical Mesh Matrix (1999), 40 descendants of its own
- K021160: Dermmatrix Surgical Mesh (2002), 38 descendants of its own
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own
- K051485: Ams Pelvic Floor Repair System (2005), 17 descendants of its own
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08 (2008), 12 descendants of its own

## Indications for 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 urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

Source page: https://510kreport.com/device/K982403
Methodology: https://510kreport.com/methodology