Clear Guide TP Access Tool

FDA UDI

Class II (US FDA UDI)

by Clear Guide Medical

Identity

Trade Name: Clear Guide TP Access Tool 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. FDA UDI
Model / Reference: CGPAT 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. FDA UDI

Identifiers

Catalog Number: CG-PAT FDA UDI
Primary DI / UDI-DI: B201CGPAT0 FDA UDI
510(k) Number: K234030 FDA UDI
FDA Product Code: ITX FDA UDI
OIJ FDA UDI
JAC FDA UDI
CCX FDA UDI
GMDN Term: MRI-oriented needle guide positioner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
892.1640 FDA UDI
868.6820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Patient positioner base plate MRI-oriented needle guide positioner

Clear Guide TP Access Tool 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.

Clear Guide TP Access Frame — Clear Guide Medical · Class II
Clear Guide TP Access Posts — Clear Guide Medical · Class II

Cleared under the same submission

K234030 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Clear Guide Medical

Sources (1)

FDA UDI baa08b20-365d-4af9-b2a2-99a91fcc0c5c 36 fields · synced Jun 9, 2026