Identity
- Trade Name
- OES BRONCHOFIBERSCOPE FDA UDI
- Generic Name
- Flexible fibreoptic bronchoscope FDA UDI
- Device Name
- BF-N20 2.2MM DIA W/O CH 55CM LENGTH FDA UDI
- Model / Reference
- OLYMPUS BF TYPE N20 FDA UDI
- Description
- BF-N20 2.2MM DIA W/O CH 55CM LENGTH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170051142 FDA UDI
- 510(k) Number
- K910423 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible fibreoptic 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible fibreoptic bronchoscope
Oes Bronchofiberscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic bronchoscope.
- FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- FIBER BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- PENTAX — HOYA CORPORATION · Class II
- PENTAX — HOYA CORPORATION · Class II
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE N20 — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K910423 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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 216e1c8d-a805-4ee9-9ff7-fce25a6f2529 35 fields · synced Jun 1, 2026