Identity
- Trade Name
- PENTAX Medical FDA UDI
- Generic Name
- Flexible ultrasound bronchoscope FDA UDI
- Device Name
- PENTAX Medical Round-Trip Carrying Case VE-B24 FDA UDI
- Model / Reference
- VE-B24 FDA UDI
- Description
- PENTAX Medical Round-Trip Carrying Case VE-B24 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333232130 FDA UDI
- 510(k) Number
- K183516 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible ultrasound bronchoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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 bronchoscope
PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible ultrasound bronchoscope.
- FUJIFILM — FUJIFILM Corporation · Class II
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
- ULTRASOUND BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
Cleared under the same submission
K183516 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 340842d2-54a7-4327-92a6-0b16abde5628 34 fields · synced May 30, 2026