Modus IR SYN-0990
Modus IR SYN-0990 is a Class II device made by Synaptive Medical Inc, cleared under FDA 510(k) K231986 on 25 Mar 2024 and listed in FDA GUDID since 2 Apr 2024 (UDI-DI 00670082000603), 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 | Number00670082000603 | Date2 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231986 | Date25 Mar 2024 | StatusActive |
Official records
- AccessGUDID record 00670082000603
- FDA 510(k) database K231986
Across registries
- FDA 510(k) K231986 decided 25 Mar 2024 Active
- FDA GUDID UDI-DI 00670082000603 listed 2 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K231986
- Listed FDA GUDID 00670082000603
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Modus IR
- Generic name
- Surgical microscope fluorescent angiography system
- Model / reference
- SYN-0990
- Primary DI / UDI-DI
- 00670082000603
- 510(k) Number
- FDA product code
- IZI
- GMDN term
- Surgical microscope fluorescent angiography system
- Device class
- Class II
- Regulation number
- 892.1600
- GUDID distribution status
- In Commercial Distribution
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