510(k) K251955
K251955 is an FDA 510(k) premarket notification submitted by Davol Inc., Subsidiary of C. R. Bard, Inc. for the device "Onflex Mesh". The FDA issued a decision of Substantially Equivalent on July 24, 2025. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Davol Inc., Subsidiary of C. R. Bard, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2025
- Date Received
- June 25, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type