Biopsy needles
Leapmed
by Suzhou Leapmed Healthcare Corporation
A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
Leapmed 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 |
|---|---|---|---|
| 28-A1810C | Length 10 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 28-A1816C | Length 16 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 28-BG1420 | Length 20 cm; Needle Gauge 14 G | MR Unsafe | Available |
| 28-BG1616 | Length 16 cm; Needle Gauge 16 G | MR Unsafe | Available |
| 28-BG1620 | Length 20 cm; Needle Gauge 16 G | MR Unsafe | Available |
| 28-BG1620C | Length 20 cm; Needle Gauge 16 G | MR Unsafe | Available |
| 28-BG1816 | Length 16 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 28-BG1820 | Length 20 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 28-BG1825 | Length 25 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 28-CN15G | Length 13.0 cm | MR Unsafe | Available |
| 28-CN15G7 | Length 9.0 cm | MR Unsafe | Available |
| 28-CN17G | Length 13.0 cm | MR Unsafe | Available |
| 28-CN17G7 | Length 9.0 cm | MR Unsafe | Available |
| 28-CN17GT | Length 12.0 cm | MR Unsafe | Available |
| 28-CO1820 | Length 17.8 cm | MR Unsafe | Available |
| 28-FN15G | Length 13.0 cm | MR Unsafe | Available |
| 28-FN15G7 | Length 9.0 cm | MR Unsafe | Available |
| 11100606 | Length 10 cm; Needle Gauge 16 G | MR Unsafe | Available |
| 11100706 | Length 16 cm; Needle Gauge 16 G | MR Unsafe | Available |
| 11100806 | Length 10 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 11100906 | Length 16 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 11101006 | Length 20 cm; Needle Gauge 18 G | MR Unsafe | Available |
| 11101206 | Length 10 cm; Needle Gauge 14 G | MR Unsafe | Available |
| 11101506 | Length 16 cm; Needle Gauge 14 G | MR Unsafe | Available |
| 11101606 | Length 20 cm; Needle Gauge 16 G | MR Unsafe | Available |
FDA clearances
- 510(k) K212822 July 2022
- 510(k) K212820 July 2022
Procedures that use biopsy needles
Frequently asked questions
What is Leapmed used for?
A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
Who makes Leapmed?
Leapmed is made by Suzhou Leapmed Healthcare Corporation. It is listed under biopsy needles and systems in our device library.
What sizes does Leapmed come in?
Sizes listed for Leapmed: Length: 9–25 cm; Needle Gauge: 14–18 G. Confirm availability with the manufacturer's instructions for use.
Is Leapmed MRI safe?
The FDA device database lists Leapmed as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Leapmed FDA cleared?
Leapmed is covered by FDA submissions K212822, K212820.
How do I contact a Suzhou Leapmed Healthcare Corporation sales representative?
Suzhou Leapmed Healthcare Corporation has not listed representatives on LA Vascular yet. Visit the Suzhou Leapmed Healthcare Corporation 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.