VersaCoat Flowable Hydrogel VTP-12G1
VersaCoat Flowable Hydrogel VTP-12G1 is a Class II device made by Alafair Biosciences, Inc., cleared under FDA 510(k) K251505 on 22 Jul 2025 (1 earlier submission) and listed in FDA GUDID since 21 Dec 2025 (UDI-DI B454VTP12G10), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB454VTP12G10 | Date21 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK251505 | Date22 Jul 2025 | StatusActive |
Official records
- FDA 510(k) database K251505
- FDA 510(k) database K251655
Across registries
- FDA 510(k) K251505 decided 22 Jul 2025 Active
- FDA GUDID UDI-DI B454VTP12G10 listed 21 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K251655
- Cleared FDA 510(k) K251505
- Listed FDA GUDID B454VTP12G10
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VersaCoat Flowable Hydrogel
- Generic name
- Nerve guide, synthetic polymer, bioabsorbable
- Model / reference
- VTP-12G1
- Primary DI / UDI-DI
- B454VTP12G10
- FDA product code
- OWW, JXI
- GMDN term
- Nerve guide, synthetic polymer, bioabsorbable
- Device class
- Class II
- Regulation number
- 878.3300, 882.5275
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Total Volume — 1 Milliliter
Similar devices
Other devices filed under FDA product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon).
- BioBrace Implant by Biorez, Inc.
- STR GRAFT by Soft Tissue Regeneration, Inc.
- FlexBand; FlexPatch; FlexBand Plus by International Life Sciences
- BioBrace® Reinforced Implant by Conmed Corporation
- Rotium by NANOFIBER SOLUTIONS LLC
- BioBrace® by Conmed Corporation
- SpinMedix Absorbable Fibrous Membrane by Celestray Biotech Company, LLC.,