Biopsy needles
Bio-Feather
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Bio-Feather 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 |
|---|---|---|---|
| BF12100-02 | — | MR Unsafe | Available |
| BF12100-C2 | — | MR Unsafe | Available |
| BF12160-02 | — | MR Unsafe | Available |
| BF12160-C2 | — | MR Unsafe | Available |
| BF14100-02 | — | MR Unsafe | Available |
| BF14100-C2 | — | MR Unsafe | Available |
| BF14160-02 | — | MR Unsafe | Available |
| BF14160-C2 | — | MR Unsafe | Available |
| BF14200-C2 | — | MR Unsafe | Available |
| BF16080-C2 | — | MR Unsafe | Available |
| BF16100-02 | — | MR Unsafe | Available |
| BF16100-C2 | — | MR Unsafe | Available |
| BF16160-02 | — | MR Unsafe | Available |
| BF16160-C2 | — | MR Unsafe | Available |
| BF16200-02 | — | MR Unsafe | Available |
| BF16200-C2 | — | MR Unsafe | Available |
| BF18080-C2 | — | MR Unsafe | Available |
| BF18100-02 | — | MR Unsafe | Available |
| BF18200-02 | — | MR Unsafe | Available |
| BF18200-C2 | — | MR Unsafe | Available |
| BF20080-C2 | — | MR Unsafe | Available |
| BF20100-02 | — | MR Unsafe | Available |
| BF20160-02 | — | MR Unsafe | Available |
| BF20200-02 | — | MR Unsafe | Available |
| BF20200-C2 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K142125 December 2015
Procedures that use biopsy needles
Frequently asked questions
What is Bio-Feather used for?
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Who makes Bio-Feather?
Bio-Feather is made by Medax Srl Unipersonale. It is listed under biopsy needles and systems in our device library.
What sizes does Bio-Feather come in?
The FDA device database does not list sizes for Bio-Feather. Check the instructions for use or ask a Medax Srl Unipersonale representative.
Is Bio-Feather MRI safe?
The FDA device database lists Bio-Feather as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Bio-Feather FDA cleared?
Bio-Feather is covered by FDA submission K142125.
How do I contact a Medax Srl Unipersonale sales representative?
Medax Srl Unipersonale has not listed representatives on LA Vascular yet. Visit the Medax Srl Unipersonale 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.