Biopsy needles
Spirotome
by Bioncise
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.
Spirotome 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 |
|---|---|---|---|
| SS08MR | — | MR Conditional | Available |
| SS0808 | — | MR Conditional | Available |
| SS0810 | — | MR Conditional | Available |
| SS0815 | — | MR Conditional | Available |
| SS0820 | — | MR Conditional | Available |
| SS10MR | — | MR Conditional | Available |
| SS1006 | — | MR Conditional | Available |
| SS1008 | — | MR Conditional | Available |
| SS1406 | — | MR Conditional | Available |
| SS1408 | — | MR Conditional | Available |
| SS1410 | — | MR Conditional | Available |
| SS1415 | — | MR Conditional | Available |
FDA clearances
- 510(k) K080095 April 2008
Procedures that use biopsy needles
Frequently asked questions
What is Spirotome 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 Spirotome?
Spirotome is made by Bioncise. It is listed under biopsy needles and systems in our device library.
What sizes does Spirotome come in?
The FDA device database does not list sizes for Spirotome. Check the instructions for use or ask a Bioncise representative.
Is Spirotome MRI safe?
The FDA device database lists Spirotome as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Spirotome FDA cleared?
Spirotome is covered by FDA submission K080095.
How do I contact a Bioncise sales representative?
Bioncise has not listed representatives on LA Vascular yet. Visit the Bioncise 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.