Clearance Summary
Phasix ST Umbilical Hernia Patch received FDA 510(k) clearance under submission number K243241, sponsored by Davol, Inc., A Subsidiary of C.R. Bard, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-02-19.
- Submission: K243241
- Applicant / Sponsor: Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2025-02-19
Classification & Regulation
This clearance is catalogued under FDA product code OWT and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.