Clear Guide TP Access Tool

Basic Information

• Brand Name: Clear Guide TP Access Tool
• Primary DI: B201CGPAT0
• Version / Model: CGPAT
• Catalog Number: CG-PAT
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Labeler DUNS: 965399905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-10
• Public Version: 2
• Public Version Date: 2025-03-18
• Public Version Status: Update
• Public Device Record Key: baa08b20-365d-4af9-b2a2-99a91fcc0c5c

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
OIJ	Biopsy Needle Guide Kit	Radiology	892.1560	2
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	892.1640	1
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61129	Patient positioner base plate	A device in the form of a non-mirrored flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices (not included) can be attached [e.g., arch frame, thermoplastic mask, headrest, head positioner]. It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.	No	Active
64457	MRI-oriented needle guide positioner	A manually-adjustable device designed to hold and enable positioning of a needle guide using real-time magnetic resonance imaging (MRI) so that the needle can be manually inserted into a patient at a precise location/angle; it is not intended to introduce the needle. It is a frame-like device (e.g., holder with moveable plates) made of MRI-compatible materials designed to be attached to the patient’s body. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B201CGPAT0	HIBCC
Package	B201CGPAT1	HIBCC	Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K234030	000