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ChannelScope, Long, 10K

FDA UDI

Class II (US FDA UDI)

by Clarus Medical, Llc

Identity

Trade Name
ChannelScope, Long, 10K FDA UDI
Generic Name
Rigid optical intracranial/spinal endoscope, single-use FDA UDI
Device Name
ChannelScope, 10K Pixels, Long, 21.6cm Working Length FDA UDI
Model / Reference
2232-002 FDA UDI
Description
ChannelScope, 10K Pixels, Long, 21.6cm Working Length FDA UDI

Identifiers

Catalog Number
2232-002 FDA UDI
Primary DI / UDI-DI
00810004820937 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, Long, 10K 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.

Cleared under the same submission

K945633 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clarus Medical, Llc

Sources (1)

  • FDA UDI 9e7cafda-7f6c-41b0-8d71-42f96e5e2ec7 36 fields · synced May 31, 2026