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Clear Guide TP Access Frame

FDA UDI

Class II (US FDA UDI)

by Clear Guide Medical

Identity

Trade Name
Clear Guide TP Access Frame FDA UDI
Generic Name
MRI-oriented needle guide positioner FDA UDI
Device Name
The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT). FDA UDI
Model / Reference
CGTPF FDA UDI
Description
The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT). FDA UDI

Identifiers

Catalog Number
CG-TPF FDA UDI
Primary DI / UDI-DI
B201CGTPF0 FDA UDI
510(k) Number
K234030 FDA UDI
FDA Product Code
ITX FDA UDI
JAC FDA UDI
GMDN Term
MRI-oriented needle guide positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1640 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: MRI-oriented needle guide positioner

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

Similar devices

Also classified as MRI-oriented needle guide positioner.

Cleared under the same submission

K234030 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 d19215aa-e537-4415-893c-79587befb852 36 fields · synced Jun 9, 2026