HyperSuture TSS-209C
HyperSuture TSS-209C is a Class II device made by Threadstone LLC, cleared under FDA 510(k) K230311 on 24 Nov 2023 and listed in FDA GUDID since 11 Oct 2024 (UDI-DI 00810129091045), 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 | Number00810129091045 | Date11 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230311 | Date24 Nov 2023 | StatusActive |
Official records
- AccessGUDID record 00810129091045
- FDA 510(k) database K230311
Across registries
- FDA 510(k) K230311 decided 24 Nov 2023 Active
- FDA GUDID UDI-DI 00810129091045 listed 11 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K230311
- Listed FDA GUDID 00810129091045
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- Withdrawn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-209C
- Primary DI / UDI-DI
- 00810129091045
- 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.