510(k) K262406
K262406 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "EluPro Antibiotic-Eluting BioEnvelope". The FDA issued a decision of Substantially Equivalent on Aug 12, 2026. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Boston Scientific has 493 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2026
- Date Received
- Jul 15, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)