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Clear Guide ONE

FDA UDI

Class II (US FDA UDI)

by Clear Guide Medical

Identity

Trade Name
Clear Guide ONE FDA UDI
Generic Name
Ultrasound imaging system application software FDA UDI
Model / Reference
CGONE FDA UDI

Identifiers

Primary DI / UDI-DI
B201CGONE0 FDA UDI
510(k) Number
K141806 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Ultrasound imaging system application software 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: Ultrasound imaging system application software

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

Similar devices

Also classified as Ultrasound imaging system application software.

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 7714baa1-8e3b-429d-9468-f1a8523c945b 33 fields · synced Jun 9, 2026