Identity
- Trade Name
- Bronchial endoscope FDA UDI
- Generic Name
- Rigid optical bronchoscope FDA UDI
- Device Name
- Autoclavable bronchial endoscope diameter 5,5mm, 0° direction of view, compatible with BRONCHOSCOPE EFER-DUMON bronchial tubes, color coded black and orange plunger tubes, and EFER ENDOSCOPY optical forceps FDA UDI
- Model / Reference
- BX-5500-FA FDA UDI
- Description
- Autoclavable bronchial endoscope diameter 5,5mm, 0° direction of view, compatible with BRONCHOSCOPE EFER-DUMON bronchial tubes, color coded black and orange plunger tubes, and EFER ENDOSCOPY optical forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700620600266 FDA UDI
- 510(k) Number
- K854414 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Rigid optical 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical bronchoscope
Bronchial endoscope by Efer Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical bronchoscope.
- PILLING — TELEFLEX INCORPORATED · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Bronchoscope — SOPRO-COMEG GmbH · Class II
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class II
- Bronchoscope — SOPRO-COMEG GmbH · Class II
- PILLING — TELEFLEX INCORPORATED · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
Cleared under the same submission
K854414 also covers:
- Adult Base — EFER ENDOSCOPY
- Adult bronchial tube — EFER ENDOSCOPY
- Adult bronchial tube — EFER ENDOSCOPY
- Adult introducer tube — EFER ENDOSCOPY
- Adult introducer tube — EFER ENDOSCOPY
- Adult loader — EFER ENDOSCOPY
- Adult loader — EFER ENDOSCOPY
- Adult plunger tube — EFER ENDOSCOPY
- Adult plunger tube — EFER ENDOSCOPY
- Adult plunger tube — EFER ENDOSCOPY
- Adult tracheal tube — EFER ENDOSCOPY
- Adult tracheal tube — EFER ENDOSCOPY
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
- Efer Endoscopy
Sources (1)
- FDA UDI 25232747-cb70-4d9e-ad15-0568af110577 34 fields · synced Jun 1, 2026