Device
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 interve...
Manufacturer
CLEAR GUIDE MEDICAL, INC.
CLEAR GUIDE MEDICAL, INC.
Model: CGSG14
Catalog: CG-SG14
DI: B201CGSG140
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
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)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
91a97669-5f92-43a2-9c19-990d48536208
Distribution Status:
In Commercial Distribution
DUNS Number:
965399905
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Unit Box
Item #1 - Device ID:
B201CGSG141
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
B201CGSG140
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
B201CGSG140
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
Item #3 - Pkg Type:
Packer Shelf Box
Item #3 - Device ID:
B201CGSG142
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
4
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
B201CGSG141
Item #3 - Device ID Issuing Agency:
HIBCC
Item #4 - Pkg Type:
Mailer Box
Item #4 - Device ID:
B201CGSG143
Item #4 - Pkg Status:
In Commercial Distribution
Item #4 - Pkg Quantity:
1
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
B201CGSG142
Item #4 - Device ID Issuing Agency:
HIBCC
Item #5 - Pkg Type:
Shipper Box
Item #5 - Device ID:
B201CGSG144
Item #5 - Pkg Status:
In Commercial Distribution
Item #5 - Pkg Quantity:
16
Item #5 - Device ID Type:
Package
Item #5 - Contains DINumber:
B201CGSG142
Item #5 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 45018
Name: Needle guide, single-use
Definition:
A 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.
FDA Product Codes
IWJ
System, Applicator, Radionuclide, Manual
ITX
Transducer, Ultrasonic, Diagnostic
OIJ
Biopsy Needle Guide Kit
Premarket Submissions
Submission Number:
K234030
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gauge
Device Size - Size - @attributes - Value:
14
Device Size - Size Type:
Needle Gauge