IRIS Arthroscope TA127-130
IRIS Arthroscope TA127-130 is a Class II device made by SOLENDOS Inc., cleared under FDA 510(k) K080560 on 18 Mar 2008 and listed in FDA GUDID since 7 Jan 2025 (UDI-DI 08800147702827), active as of 23 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 | Number08800147702827 | Date7 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080560 | Date18 Mar 2008 | StatusActive |
Official records
- AccessGUDID record 08800147702827
- FDA 510(k) database K080560
Across registries
- FDA 510(k) K080560 decided 18 Mar 2008 Active
- FDA GUDID UDI-DI 08800147702827 listed 7 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K080560
- Listed FDA GUDID 08800147702827
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IRIS Arthroscope
- Generic name
- Rigid optical arthroscope, reusable
- Model / reference
- TA127-130
- Primary DI / UDI-DI
- 08800147702827
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Rigid optical arthroscope, reusable
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Rigid optical arthroscope, reusable.