HyperSuture TSS-202CN
HyperSuture TSS-202CN is a Class II device made by Threadstone LLC, cleared under FDA 510(k) K241376 on 9 Aug 2024 and listed in FDA GUDID since 23 Aug 2024 (UDI-DI 00810129090178), 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 | Number00810129090178 | Date23 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241376 | Date9 Aug 2024 | StatusActive |
Official records
- AccessGUDID record 00810129090178
- FDA 510(k) database K241376
Across registries
- FDA 510(k) K241376 decided 9 Aug 2024 Active
- FDA GUDID UDI-DI 00810129090178 listed 23 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K241376
- Listed FDA GUDID 00810129090178
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- Withdrawn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-202CN
- Primary DI / UDI-DI
- 00810129090178
- 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.