Clear Guide TP Access Posts

Basic Information

• Brand Name: Clear Guide TP Access Posts
• Primary DI: B201CGTPP0
• Version / Model: CGTPP
• Catalog Number: CG-TPP
• 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: 1
• Public Version Date: 2025-01-20
• Public Version Status: New
• Public Device Record Key: 0eeb2180-e672-4325-ab0e-183b1e7158ee

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. The device constitutes 3 pairs of posts (T, M, S) as a replacement for Clear Guide TP Access Tool (CG-PAT).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
IWJ	System, Applicator, Radionuclide, Manual	Radiology	892.5650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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	B201CGTPP0	HIBCC
Package	B201CGTPP1	HIBCC	Shelf Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K234030	000

Device Sizes

Type	Value	Unit	Text
Length	3	Inch
Length	4	Inch
Length	5	Inch