# K031332: Bard Pelvisoft Acellular Collagen Biomesh

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: May 15, 2003 after 17 days
- Product code: FTM (Mesh, Surgical)
- 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Permacol® Acellular Collagen Matrix: named in the summary without a submission number
- (no number) SurgiSIS™: named in the summary without a submission number

## Most influential descendants
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own
- K142326: HP Tissue Matrix (2014), 11 descendants of its own
- K151083: BioBridge Collagen Matrix (2016), 9 descendants of its own
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K230316: FlexBand; FlexPatch; FlexBand Plus (2023), 3 descendants of its own

## Indications for use
Bard® PelviSoft™ Acellular Collagen BioMesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for urethral procedures, vaginal prolapse, and reconstruction of the pelvic floor.

Source page: https://510kreport.com/device/K031332
Methodology: https://510kreport.com/methodology