Dragonfly Digital Controller DFE-MD-000658
Dragonfly Digital Controller DFE-MD-000658 is an endoscopic control/video-imaging system (FDA Class II; FDA product code FET, Endoscopic Video Imaging System/Component, Gastroenterology-Urology) made by CenterPoint Systems LLC, cleared under FDA 510(k) K233752 on 2 May 2024 and listed in FDA GUDID since 22 Jul 2024 (UDI-DI 00810024670277), 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 | Number00810024670277 | Date22 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233752 | Date2 May 2024 | StatusActive |
Official records
- AccessGUDID record 00810024670277
- FDA 510(k) database K233752
Across registries
- FDA 510(k) K233752 decided 2 May 2024 Active
- FDA GUDID UDI-DI 00810024670277 listed 22 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K233752
- Listed FDA GUDID 00810024670277
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dragonfly Digital Controller
- Generic name
- Endoscopic control/video-imaging system
- Model / reference
- DFE-MD-000658
- Primary DI / UDI-DI
- 00810024670277
- 510(k) Number
- FDA product code
- FET
- GMDN term
- Endoscopic control/video-imaging system
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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