Identity
- Trade Name
- Dragonfly Digital Controller FDA UDI
- Generic Name
- Endoscopic control/video-imaging system FDA UDI
- Model / Reference
- DFE-MD-000658 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810024670277 FDA UDI
- 510(k) Number
- K233752 FDA UDI
- FDA Product Code
- FET FDA UDI
- GMDN Term
- Endoscopic control/video-imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic control/video-imaging system
Dragonfly Digital Controller by CenterPoint Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic control/video-imaging system.
- SPiN Vision Video Processor — VERAN MEDICAL TECHNOLOGIES INC. · Class II
- MAGNIFICATION CONTROLLER — Olympus Medical Systems Corporation · Class II
- EvoEndo Controller — Evoendo, Inc. · Class II
- Pegasus — A.M. SURGICAL, INC. · Class II
- Saneso — Saneso, Inc. · Class II
- Monarch Endoscopy Controller — Auris Health, Inc. · Class II
Cleared under the same submission
K233752 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CenterPoint Systems LLC
Sources (1)
- FDA UDI a3cd8ef8-7bc8-4637-8485-b9a88bb79e78 33 fields · synced Jun 9, 2026