Identity
- Trade Name
- Axonpen FDA UDI
- Generic Name
- Surgical irrigation/aspiration cannula, illuminating, single-use FDA UDI
- Device Name
- Axonpen Endoscope FDA UDI
- Model / Reference
- AH-50-110 FDA UDI
- Description
- Axonpen Endoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000321303 FDA UDI
- 510(k) Number
- K201308 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Surgical irrigation/aspiration cannula, illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation/aspiration cannula, illuminating, single-use
Axonpen by Clearmind Biomedical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration cannula, illuminating, single-use.
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Axonpen System — Clearmind Biomedical · Class II
Cleared under the same submission
K201308 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
- Clearmind Biomedical
Sources (1)
- FDA UDI 9bf4bc14-4894-4553-8188-8536e2d6016a 34 fields · synced Jun 8, 2026