# K261543: Phasix ST Parastomal Hernia Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- Decided: Sep 28, 2026 after 143 days
- Product code: OWT (Mesh, Surgical, Absorbable, Abdominal Hernia)
- 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
Longest line of descent: 5 generations back to K921895 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162934: Biodesign Parastomal Hernia Repair Graft, Cook Biotech Incorporated (2017) Summary page 5.

## Indications for use
Phasix™ ST Parastomal Hernia Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures for the repair of parastomal hernias.

Source page: https://510kreport.com/device/K261543
Methodology: https://510kreport.com/methodology