# Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261543 |
| Device | Phasix ST Parastomal Hernia Mesh |
| Applicant | Davol, Inc., A Subsidiary of C.R. Bard, Inc. |
| Specialty / panel | General, Plastic Surgery |
| Product code | OWT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-08 |
| Decision date | 2026-09-28 |
| Review time (days) | 143 |
| Third-party review | No |
| Applicant location | Warwick, RI, US |

## Why this score
- Fast 143-day review: this device is a strong predicate for similar products.
- Posted 38 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261543). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.