HyperSuture
510(k) K230311
HyperSuture is a Class II device made by Threadstone LLC, cleared under FDA 510(k) K230311 on 24 Nov 2023, 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 | FDA 510(k)SESE | NumberK230311 | Date24 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K230311
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GAT
- FDA applicant
- Threadstone, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230311
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| HyperSuture TSS-020C | TSS-020C | 00810129090000 | — | On the market |
| HyperSuture TSS-020CN | TSS-020CN | 00810129090055 | — | On the market |
| HyperSuture TSS-024C | TSS-024C | 00810129090048 | — | On the market |
| HyperSuture TSS-024CN | TSS-024CN | 00810129090093 | — | On the market |
| HyperSuture TSS-025C | TSS-025C | 00810129090901 | — | On the market |
| HyperSuture TSS-025CN | TSS-025CN | 00810129090956 | — | On the market |
| HyperSuture TSS-029C | TSS-029C | 00810129090949 | — | On the market |
| HyperSuture TSS-038CN | TSS-038CN | 00810129094084 | — | On the market |
| HyperSuture TSS-200C | TSS-200C | 00810129090109 | — | On the market |
| HyperSuture TSS-204C | TSS-204C | 00810129090147 | — | On the market |
| HyperSuture TSS-204CN | TSS-204CN | 00810129090192 | — | On the market |
| HyperSuture TSS-205C | TSS-205C | 00810129091007 | — | On the market |
| HyperSuture TSS-205CL | TSS-205CL | 00810129091502 | — | On the market |
| HyperSuture TSS-205CN | TSS-205CN | 00810129091052 | — | On the market |
| HyperSuture TSS-209C | TSS-209C | 00810129091045 | — | On the market |
| HyperSuture TSS-209CN | TSS-209CN | 00810129091090 | — | On the market |
| HyperSuture TSS-212C | TSS-212C | 00810129091526 | — | On the market |
| HyperSuture TSS-212CN | TSS-212CN | 00810129091564 | — | On the market |
| HyperSuture TSS-251CN | TSS-251CN | 00810129092585 | — | On the market |
| HyperSuture TSS-500C | TSS-500C | 00810129090208 | — | On the market |
| HyperSuture TSS-504C | TSS-504C | 00810129091106 | — | On the market |
| HyperSuture TSS-508C | TSS-508C | 00810129091144 | — | On the market |
| HyperSuture TSS-508CN | TSS-508CN | 00810129091199 | — | On the market |
| HyperSuture TSS-509C | TSS-509C | 00810129091717 | — | On the market |
| HyperSuture TSS-509CN | TSS-509CN | 00810129091724 | — | On the market |
| HyperSuture TSS-511C | TSS-511C | 00810129090246 | — | On the market |
| HyperSuture TSS-511CN | TSS-511CN | 00810129090291 | — | On the market |
| HyperSuture TSS-518CN | TSS-518CN | 00810129092622 | — | On the market |
| HyperSuture TST-050N | TST-050N | 00810129090352 | — | On the market |
| HyperSuture TST-054 | TST-054 | 00810129090345 | — | On the market |
| HyperSuture TST-054N | TST-054N | 00810129090390 | — | On the market |
| HyperSuture TST-059 | TST-059 | 00810129091243 | — | On the market |
| HyperSuture TST-150N | TST-150N | 00810129090451 | — | On the market |
| HyperSuture TST-150NL | TST-150NL | 00810129092141 | — | On the market |
| HyperSuture TST-152 | TST-152 | 00810129091304 | — | On the market |
| HyperSuture TST-152NL | TST-152NL | 00810129091915 | — | On the market |
| HyperSuture TST-156 | TST-156 | 00810129091342 | — | On the market |
| HyperSuture TST-156N | TST-156N | 00810129091397 | — | On the market |
| HyperSuture TST-161 | TST-161 | 00810129090444 | — | On the market |
| HyperSuture TST-161N | TST-161N | 00810129090499 | — | On the market |
| HyperSuture TST-162NL | TST-162NL | 00810129091946 | — | On the market |
| HyperSuture TST-163NL | TST-163NL | 00810129092172 | — | On the market |
| HyperSuture TST-250 | TST-250 | 00810129090505 | — | On the market |
| HyperSuture TST-250N | TST-250N | 00810129090550 | — | On the market |
| HyperSuture TST-252 | TST-252 | 00810129091403 | — | On the market |
| HyperSuture TST-252N | TST-252N | 00810129091458 | — | On the market |
| HyperSuture TST-256 | TST-256 | 00810129091441 | — | On the market |
| HyperSuture TST-261N | TST-261N | 00810129090598 | — | On the market |
| HyperSuture TST-262 | TST-262 | 00810129092035 | — | On the market |
| HyperSuture TST-263NL | TST-263NL | 00810129092103 | — | On the market |