Biopsy needles
Spirotome Spine
by Bioncise
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.
Spirotome Spine 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 |
|---|---|---|---|
| SS08SP | — | MR Conditional | Available |
| SS10SP | — | MR Conditional | Available |
FDA clearances
- 510(k) K080095 April 2008
Procedures that use biopsy needles
Frequently asked questions
What is Spirotome Spine used for?
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.
Who makes Spirotome Spine?
Spirotome Spine is made by Bioncise. It is listed under biopsy needles and systems in our device library.
What sizes does Spirotome Spine come in?
The FDA device database does not list sizes for Spirotome Spine. Check the instructions for use or ask a Bioncise representative.
Is Spirotome Spine MRI safe?
The FDA device database lists Spirotome Spine as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Spirotome Spine FDA cleared?
Spirotome Spine 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.