pde-neo C10935-40
pde-neo C10935-40 is a Class II device made by Hamamatsu Photonics K.K., cleared under FDA 510(k) K133719 on 27 Mar 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04582389010093), 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 | Number04582389010093 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133719 | Date27 Mar 2014 | StatusActive |
Official records
- AccessGUDID record 04582389010093
- FDA 510(k) database K133719
Across registries
- FDA 510(k) K133719 decided 27 Mar 2014 Active
- FDA GUDID UDI-DI 04582389010093 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K133719
- Listed FDA GUDID 04582389010093
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- pde-neo
- Generic name
- Surgical microscope fluorescent angiography system
- Model / reference
- C10935-40
- Primary DI / UDI-DI
- 04582389010093
- 510(k) Number
- FDA product code
- OWN, IZI
- GMDN term
- Surgical microscope fluorescent angiography system
- Device class
- Class II
- Regulation number
- 876.1500, 892.1600
- GUDID distribution status
- In Commercial Distribution
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