Biopsy needles
Fast-Cut
by Sterylab Srl
An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) 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 is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.
Fast-Cut 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 |
|---|---|---|---|
| FAST-CUT | Length 15 cm | Not stated | Available |
| FAST-CUT | Length 25 cm | Not stated | Available |
| FAST-CUT | Length 20 cm | Not stated | Available |
| FAST-CUT | Length 25 cm | Not stated | Available |
| FAST-CUT | Length 20 cm | Not stated | Available |
| FAST-CUT | Length 25 cm | Not stated | Available |
| FAST-CUT | Length 25 cm | Not stated | Available |
| FAST-CUT | Length 20 cm | Not stated | Available |
| FAST-CUT | Length 20 cm | Not stated | Available |
| FAST-CUT | Length 15 cm | Not stated | Available |
| FAST-CUT | Length 15 cm | Not stated | Available |
| FAST-CUT | Length 15 cm | Not stated | Available |
FDA clearances
- 510(k) K051506 July 2005
Procedures that use biopsy needles
Frequently asked questions
What is Fast-Cut used for?
An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) 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 is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.
Who makes Fast-Cut?
Fast-Cut is made by Sterylab Srl. It is listed under biopsy needles and systems in our device library.
What sizes does Fast-Cut come in?
Sizes listed for Fast-Cut: Length: 15–25 cm. Confirm availability with the manufacturer's instructions for use.
Is Fast-Cut MRI safe?
The FDA device database entry for Fast-Cut does not state its MRI safety status. Check the labeling before MRI.
Is Fast-Cut FDA cleared?
Fast-Cut is covered by FDA submission K051506.
How do I contact a Sterylab Srl sales representative?
Sterylab Srl has not listed representatives on LA Vascular yet. Visit the Sterylab Srl 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.