Tapes
Tapes is a Class II device made by Endo Tools Therapeutics, cleared under FDA 510(k) K211309 on 7 Dec 2021 and listed in FDA GUDID since 19 Jul 2022 (UDI-DI 05425029282094), active as of 21 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 | Number05425029282094 | Date19 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211309 | Date7 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 05425029282094
- FDA 510(k) database K211309
Across registries
- FDA 510(k) K211309 decided 7 Dec 2021 Active
- FDA GUDID UDI-DI 05425029282094 listed 19 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K211309
- Listed FDA GUDID 05425029282094
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Suturing unit, single-use
- Model / reference
- TAPES
- Primary DI / UDI-DI
- 05425029282094
- 510(k) Number
- FDA product code
- OCW
- GMDN term
- Suturing unit, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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