Pde-GEN3 C13999-40
Pde-GEN3 C13999-40 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 1 Jun 2023 (UDI-DI 04582389010871), 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 | Number04582389010871 | Date1 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133719 | Date27 Mar 2014 | StatusActive |
Official records
- AccessGUDID record 04582389010871
- FDA 510(k) database K133719
Across registries
- FDA 510(k) K133719 decided 27 Mar 2014 Active
- FDA GUDID UDI-DI 04582389010871 listed 1 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K133719
- Listed FDA GUDID 04582389010871
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pde-GEN3
- Generic name
- Surgical microscope fluorescent angiography system
- Model / reference
- C13999-40
- Primary DI / UDI-DI
- 04582389010871
- 510(k) Number
- FDA product code
- IZI, OWN
- GMDN term
- Surgical microscope fluorescent angiography system
- Device class
- Class II
- Regulation number
- 892.1600, 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).
- SPY INTRAOPERATIVE IMAGING SYSTEM by Novadaq Technologies Inc
- EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) by SurgVision GmbH
- VIDEO SYSTEM INTERFACE MODELS by Perkins Mfg. Co.
- SPY FLUORESCENT IMAGING SYSTEM by Novadaq Technologies Inc
- GEMNET by GE MEDICAL SYSTEMS, INC.
- SPY Elite Intraoperative Perfusion Assessment System by Novadaq Technologies Ulc. (Now A Part of Stryker)
- X-RAY ANGIOGRAPHIC SYSTEM by Camtronics, Ltd.
- BI-N by Xre Corp.
- LEG'MAP OPTION by GE MEDICAL SYSTEMS, INC.