# K063178: Bard Collamend Implant, Models 1175102, 1175103, 1175104, 1175105, 1175106

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 21, 2006 after 33 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Bard CollaMend® Implant (Davol, Inc.): named in the summary without a submission number
- (no number) Permacol™ Implant (Tissue Science Laboratories, PLC.): named in the summary without a submission number
- (no number) Mersilene® Polyester Fiber Mesh (Ethicon, Inc.): named in the summary without a submission number
- (no number) SIS Plastic Surgery Matrix (Cook Biotech Incorporated): named in the summary without a submission number
- (no number) CosMatrix (TEI Biosciences, Inc.): named in the summary without a submission number

## Indications for use
The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or ruptured soft tissue membranes or reinforcement in plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K063178
Methodology: https://510kreport.com/methodology