510(k) K251505
K251505 is an FDA 510(k) premarket notification submitted by Alafair Biosciences for the device "VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)". The FDA issued a decision of Substantially Equivalent on July 22, 2025. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Alafair Biosciences has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2025
- Date Received
- May 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type