FDA.reportPublic FDA data

Clear Guide TP Access Tool

Primary DI
B201CGPAT0
Brand
Clear Guide TP Access Tool
Company
CLEAR GUIDE MEDICAL, INC.
Model
CGPAT
Catalog number
CG-PAT
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.
Published
2025-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
ITXTransducer, Ultrasonic, Diagnostic
JACSystem, X-Ray, Film Marking, Radiographic
OIJBiopsy Needle Guide Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
ITXTransducer, Ultrasonic, DiagnosticRadiology2
JACSystem, X-Ray, Film Marking, RadiographicRadiology1
OIJBiopsy Needle Guide KitRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234030000Clear Guide SCENERGYClear Guide Medical2024-01-17JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B201CGPAT1PackageHIBCC1In Commercial Distribution
B201CGPAT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
MRI-oriented needle guide positionerA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (443) 267-7661support@clearguidemedical.com

Regulatory Flags#

DUNS number
965399905
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B201CGSG140Clear Guide SteriGRIDCGSG14CG-SG142026-05-11
B201CGTT0Clear Guide TipTAGCGTT2017-04-07
B201CGVM0Clear Guide VisiMARKERCGVM2016-09-21
B201CGSG0Clear Guide SteriGRIDCGSGCG-SG2025-01-10
B201CGVM20Clear Guide VisiMARKER IICGVM2CG-VM22022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCGVM2NSCG-VM2-NS2022-10-04
B201CGVMNS0Clear Guide VisiMARKER Non-SterileCGVMNSCG-VM-NS2022-10-04
B201CGOH0Clear Guide Optical HeadCGOHCG-OH2016-09-21
B201CGOHM0Clear Guide Optical HeadCGOHMCG-OH-M2022-10-07
B201CGSCENERGYTP0Clear Guide SCENERGY TPCGSCENERGYTPCG-SCENERGY-TP2025-01-10
B201CGTPF0Clear Guide TP Access FrameCGTPFCG-TPF2025-01-10
B201CGTPP0Clear Guide TP Access PostsCGTPPCG-TPP2025-01-10
B201CGCORE130Clear Guide CORECGCORE13CG-CORE-132022-10-06
B201CGCORE170Clear Guide CORECGCORE17CG-CORE172022-10-07
B201CGCORE240Clear Guide CORECGCORE24CG-CORE242022-10-07
B201CGCORE24MR0Clear Guide CORECGCORE24MRCG-CORE24-MR2022-10-06
B201CGSMM0Clear Guide SteriMASKCGSMMCG-SM-M2022-10-03
B201CGSCENERGY0Clear Guide SCENERGYCGSCENERGY2016-09-21
B201CGSM0Clear Guide SteriMASKCGSM2016-09-21
B201CGONE0Clear Guide ONECGONE2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
06975122554851MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554868MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554875MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCCCX2024-08-12
08059174749873MED-GUIDE 1MEDAX SRL UNIPERSONALEOIJ2024-07-23