HyperSuture TSS-212C
HyperSuture TSS-212C is a Class II device made by Threadstone LLC, cleared under FDA 510(k) K234079 on 10 May 2024 (1 earlier submission) and listed in FDA GUDID since 11 Oct 2024 (UDI-DI 00810129091526), active as of 22 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 | Number00810129091526 | Date11 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK234079 | Date10 May 2024 | StatusActive |
Official records
- AccessGUDID record 00810129091526
- FDA 510(k) database K234079
- FDA 510(k) database K230311
Across registries
- FDA 510(k) K234079 decided 10 May 2024 Active
- FDA GUDID UDI-DI 00810129091526 listed 11 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K230311
- Cleared FDA 510(k) K234079
- Listed FDA GUDID 00810129091526
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HyperSuture
- Generic name
- Polyolefin/fluoropolymer suture, multifilament
- Model / reference
- TSS-212C
- Primary DI / UDI-DI
- 00810129091526
- FDA product code
- GAT
- GMDN term
- Polyolefin/fluoropolymer suture, multifilament
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Polyolefin/fluoropolymer suture, multifilament.