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Clear Guide Optical Head

FDA UDI

Class II (US FDA UDI)

by Clear Guide Medical

Identity

Trade Name
Clear Guide Optical Head FDA UDI
Generic Name
Radiological video camera patient positioning/tracking system camera FDA UDI
Device Name
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. FDA UDI
Model / Reference
CGOH FDA UDI
Description
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. FDA UDI

Identifiers

Catalog Number
CG-OH FDA UDI
Primary DI / UDI-DI
B201CGOH0 FDA UDI
510(k) Number
K141806 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Radiological video camera patient positioning/tracking system camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Optical surgical navigation device tracking systemRadiological video camera patient positioning/tracking system camera

Clear Guide Optical Head by Clear Guide Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological video camera patient positioning/tracking system camera.

Cleared under the same submission

K141806 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clear Guide Medical

Sources (1)

  • FDA UDI b2ac64ea-265b-42c1-a591-e29a1b2e2573 37 fields · synced Jun 9, 2026