FDA.reportPublic FDA data

Clear Guide SteriGRID

Primary DI
B201CGSG0
Brand
Clear Guide SteriGRID
Company
CLEAR GUIDE MEDICAL, INC.
Model
CGSG
Catalog number
CG-SG
Device description
The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)
Published
2025-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IWJSystem, Applicator, Radionuclide, Manual
OIJBiopsy Needle Guide Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IWJSystem, Applicator, Radionuclide, ManualRadiology1
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
B201CGSG1PackageHIBCC1In Commercial Distribution
B201CGSG2PackageHIBCC4In Commercial Distribution
B201CGSG3PackageHIBCC1In Commercial Distribution
B201CGSG4PackageHIBCC16In Commercial Distribution
B201CGSG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge14Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B201CGOH0Clear Guide Optical HeadCGOHCG-OH2016-09-21
B201CGTT0Clear Guide TipTAGCGTT2017-04-07
B201CGVM0Clear Guide VisiMARKERCGVM2016-09-21
B201CGCORE170Clear Guide CORECGCORE17CG-CORE172022-10-07
B201CGCORE240Clear Guide CORECGCORE24CG-CORE242022-10-07
B201CGOHM0Clear Guide Optical HeadCGOHMCG-OH-M2022-10-07
B201CGCORE130Clear Guide CORECGCORE13CG-CORE-132022-10-06
B201CGCORE24MR0Clear Guide CORECGCORE24MRCG-CORE24-MR2022-10-06
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
B201CGSG140Clear Guide SteriGRIDCGSG14CG-SG142026-05-11
B201CGPAT0Clear Guide TP Access ToolCGPATCG-PAT2025-01-10
B201CGSCENERGYTP0Clear Guide SCENERGY TPCGSCENERGYTPCG-SCENERGY-TP2025-01-10
B201CGTPF0Clear Guide TP Access FrameCGTPFCG-TPF2025-01-10
B201CGTPP0Clear Guide TP Access PostsCGTPPCG-TPP2025-01-10
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
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04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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