Identity
- Trade Name
- COLONOVIDEOSCOPE FDA UDI
- Generic Name
- Flexible video colonoscope, reusable FDA UDI
- Model / Reference
- OLYMPUS CF-HQ1100DL FDA UDI
Identifiers
- Catalog Number
- N6019540 FDA UDI
- Primary DI / UDI-DI
- 04953170424281 FDA UDI
- 510(k) Number
- K222584 FDA UDI
- FDA Product Code
- FDF FDA UDIFDS FDA UDINWB FDA UDIFET FDA UDINTN FDA UDI
- GMDN Term
- Flexible video colonoscope, reusable 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video colonoscope, reusable
Colonovideoscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video colonoscope, reusable.
- PENTAX — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- Endoch — Endoch Inc · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- PENTAX — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
Cleared under the same submission
K222584 also covers:
- COLONOVIDEOSCOPE — Olympus Medical Systems Corporation
- EVIS X1 VIDEO SYSTEM CENTER — Olympus Medical Systems Corporation
- Foot holder — Olympus Medical Systems Corporation
- Footswitch Conversion cable — Olympus Medical Systems Corporation
- GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation
- PUMP REMOTE CABLE — Olympus Medical Systems Corporation
- Y/C Cable — Olympus Medical Systems Corporation
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI f3894976-8094-4d64-a6da-69be688d38d4 35 fields · synced May 30, 2026