Identity
- Trade Name
- ChannelScope FDA UDI
- Generic Name
- Rigid optical intracranial/spinal endoscope, single-use FDA UDI
- Device Name
- ChannelScope, Short, 13.0cm Working Length FDA UDI
- Model / Reference
- 2233-005 FDA UDI
- Description
- ChannelScope, Short, 13.0cm Working Length FDA UDI
Identifiers
- Catalog Number
- 2233-005 FDA UDI
- Primary DI / UDI-DI
- 00810004820654 FDA UDI
- 510(k) Number
- K945633 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Rigid optical intracranial/spinal endoscope, 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: Rigid optical intracranial/spinal endoscope, single-use
ChannelScope by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical intracranial/spinal endoscope, single-use.
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- AURORA® Surgiscope® — REBOUND THERAPEUTICS, CORPORATION · Class II
- AURORA® Surgiscope® — REBOUND THERAPEUTICS, CORPORATION · Class I
- NeuroPEN — Medtronic PS Medical · Class II
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- Aurora® Surgiscope® — Integra Lifesciences Corp. · Class II
- AURORA® Surgiscope® — REBOUND THERAPEUTICS, CORPORATION · Class I
- Channel — Medtronic PS Medical · Class II
Cleared under the same submission
K945633 also covers:
- ChannelScope — CLARUS MEDICAL, LLC
- ChannelScope, Long, 10K — CLARUS MEDICAL, LLC
- Edoscopic Dissection Probe — Medtronic PS Medical
- Edoscopic Dissection Probe — Medtronic PS Medical
- Edoscopic Dissection Probe — Medtronic PS Medical
- Edoscopic Dissection Probe — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Scissors — Medtronic PS Medical
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
- Clarus Medical, Llc
Sources (1)
- FDA UDI d1b77862-c7d2-40a5-a5fb-322be381f433 37 fields · synced May 30, 2026