Identity
- Trade Name
- SemiFlex Scope FDA UDI
- Generic Name
- Flexible fibreoptic ureteroscope FDA UDI
- Device Name
- 55 centimeter single use endoscope for urological application. FDA UDI
- Model / Reference
- MF-ENDO 55 E FDA UDI
- Description
- 55 centimeter single use endoscope for urological application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B324MFENDO55E0 FDA UDI
- 510(k) Number
- K111480 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible fibreoptic ureteroscope 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hydrogen Peroxide FDA UDI
Dimensions & Sizes
- Size
- Length — 55 Centimeter FDA UDICatheter Gauge — 9.5 French FDA UDI
Category: Flexible fibreoptic ureteroscope
SemiFlex Scope by Maxiflex, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic ureteroscope.
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Bagley — Gyrus Acmi, Inc. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Cleared under the same submission
K111480 also covers:
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
- SemiFlex Scope — MAXIFLEX, LLC
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
- Maxiflex, Llc
Sources (1)
- FDA UDI f5206442-a785-478d-86e5-6382be7f235d 35 fields · synced Jun 8, 2026