510(k) clearance
Phasix ST Parastomal Hernia Mesh
- 510(k) number
- K261543
- Applicant
- Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- Decision date
- Sep 28, 2026
- Date received
- May 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OWT
- Device type
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device class
- Class II
- Regulation
- 21 CFR 878.3300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Warwick, RI, US