Identity
- Trade Name
- PENTAX Medical FDA UDI
- Generic Name
- Flexible fibreoptic cystoscope FDA UDI
- Device Name
- PENTAX Medical Single Round-Trip Carrying Case VF-B21 FDA UDI
- Model / Reference
- VF-B21 FDA UDI
- Description
- PENTAX Medical Single Round-Trip Carrying Case VF-B21 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333246465 FDA UDI
- 510(k) Number
- K914008 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible fibreoptic cystoscope 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible fibreoptic cystoscope
PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic cystoscope.
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- FIBER CYSTOSCOPE — PENTAX of America, Inc. · Class II
Cleared under the same submission
K914008 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 353af053-9dcd-4942-b214-3a077e09113a 34 fields · synced Jun 8, 2026