Biopsy needles
Gangi-SoftGuard Coaxial Needle
by Apriomed AB
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.
Gangi-SoftGuard Coaxial Needle models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| G033 | Length 12.1 cm; Needle Gauge 12 G | MR Unsafe | Available |
| G034 | Length 7.1 cm; Needle Gauge 13 G | MR Unsafe | Available |
| G035 | Length 12.1 cm; Needle Gauge 13 G | MR Unsafe | Available |
| G036 | Length 17.1 cm; Needle Gauge 13 G | MR Unsafe | Available |
| G037 | Length 7.1 cm; Needle Gauge 15 G | MR Unsafe | Available |
| G038 | Length 12.1 cm; Needle Gauge 15 G | MR Unsafe | Available |
| G039 | Length 17.1 cm; Needle Gauge 15 G | MR Unsafe | Available |
| G040 | Length 7.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
| G041 | Length 12.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
| G042 | Length 17.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
| G046 | Length 17.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
| SG12-121 | Length 12.1 cm; Needle Gauge 12 G | MR Unsafe | Available |
| SG13-071 | Length 7.1 cm; Needle Gauge 13 G | MR Unsafe | Available |
| SG13-121 | Length 12.1 cm; Needle Gauge 13 G | MR Unsafe | Available |
| SG13-171 | Length 17.1 cm; Needle Gauge 13 G | MR Unsafe | Available |
| SG15-071 | Length 7.1 cm; Needle Gauge 15 G | MR Unsafe | Available |
| SG15-121 | Length 12.1 cm; Needle Gauge 15 G | MR Unsafe | Available |
| SG15-171 | Length 17.1 cm; Needle Gauge 15 G | MR Unsafe | Available |
| SG17-071 | Length 7.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
| SG17-121 | Length 12.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
| SG17-171 | Length 17.1 cm; Needle Gauge 17 G | MR Unsafe | Available |
FDA clearances
- 510(k) K181756 December 2018
Procedures that use biopsy needles
Frequently asked questions
What is Gangi-SoftGuard Coaxial Needle used for?
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.
Who makes Gangi-SoftGuard Coaxial Needle?
Gangi-SoftGuard Coaxial Needle is made by Apriomed AB. It is listed under biopsy needles and systems in our device library.
What sizes does Gangi-SoftGuard Coaxial Needle come in?
Sizes listed for Gangi-SoftGuard Coaxial Needle: Length: 7.1–17.1 cm; Needle Gauge: 12–17 G. Confirm availability with the manufacturer's instructions for use.
Is Gangi-SoftGuard Coaxial Needle MRI safe?
The FDA device database lists Gangi-SoftGuard Coaxial Needle as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Gangi-SoftGuard Coaxial Needle FDA cleared?
Gangi-SoftGuard Coaxial Needle is covered by FDA submission K181756.
How do I contact a Apriomed AB sales representative?
Apriomed AB has not listed representatives on LA Vascular yet. Visit the Apriomed AB company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.