SlimLine MRO-742A
SlimLine MRO-742A is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K011849 on 10 Dec 2001 and listed in FDA GUDID since 18 Oct 2016 (UDI-DI 00821925006676), 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 | Number00821925006676 | Date18 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011849 | Date10 Dec 2001 | StatusActive |
Official records
- AccessGUDID record 00821925006676
- FDA 510(k) database K011849
Across registries
- FDA 510(k) K011849 decided 10 Dec 2001 Active
- FDA GUDID UDI-DI 00821925006676 listed 18 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K011849
- Listed FDA GUDID 00821925006676
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SlimLine
- Generic name
- Rigid optical ureteroscope
- Model / reference
- MRO-742A
- Primary DI / UDI-DI
- 00821925006676
- 510(k) Number
- FDA product code
- FGB
- GMDN term
- Rigid optical ureteroscope
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Rigid optical ureteroscope.