Identity
- Trade Name
- PENTAX Medical FDA UDI
- Generic Name
- Flexible ultrasound gastroduodenoscope FDA UDI
- Device Name
- PENTAX Medical Single Round-Trip Carrying Case VE-G25 FDA UDI
- Model / Reference
- VE-G25 FDA UDI
- Description
- PENTAX Medical Single Round-Trip Carrying Case VE-G25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333230709 FDA UDI
- 510(k) Number
- K200090 FDA UDI
- FDA Product Code
- ITX FDA UDIODG FDA UDI
- GMDN Term
- Flexible ultrasound gastroduodenoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI876.1500 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible ultrasound gastroduodenoscope
PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible ultrasound gastroduodenoscope.
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- ULTRASONIC GASTROVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- ULTRASOUND GASTROSCOPE — PENTAX of America, Inc. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- ULTRASOUND GASTROSCOPE — PENTAX of America, Inc. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
Cleared under the same submission
K200090 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
- Hoya Corporation
Sources (1)
- FDA UDI a21285e1-1eea-4e88-b0d7-784f1c7ce2f0 34 fields · synced Jun 8, 2026