Biopsy needles
Medcut
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.
Medcut 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 |
|---|---|---|---|
| MC14160-00 | — | MR Unsafe | Available |
| MC14160-C0 | — | MR Unsafe | Available |
| MC16100-00 | — | MR Unsafe | Available |
| MC16100-C0 | — | MR Unsafe | Available |
| MC16100-K0 | — | MR Unsafe | Available |
| MC16160-00 | — | MR Unsafe | Available |
| MC16160-C0 | — | MR Unsafe | Available |
| MC16160-K0 | — | MR Unsafe | Available |
| MC16200-00 | — | MR Unsafe | Available |
| MC16200-C0 | — | MR Unsafe | Available |
| MC16200-K0 | — | MR Unsafe | Available |
| MC18100-00 | — | MR Unsafe | Available |
| MC18100-C0 | — | MR Unsafe | Available |
| MC18100-K0 | — | MR Unsafe | Available |
| MC18160-C0 | — | MR Unsafe | Available |
| MC18160-K0 | — | MR Unsafe | Available |
| MC18200-C0 | — | MR Unsafe | Available |
| MC18200-K0 | — | MR Unsafe | Available |
| MC18250-K0 | — | MR Unsafe | Available |
| MC18300-00 | — | MR Unsafe | Available |
| MC20100-00 | — | MR Unsafe | Available |
| MC20100-C0 | — | MR Unsafe | Available |
| MC20100-K0 | — | MR Unsafe | Available |
| MC20160-00 | — | MR Unsafe | Available |
| MC20160-C0 | — | MR Unsafe | Available |
| MC20160-K0 | — | MR Unsafe | Available |
| MC20200-00 | — | MR Unsafe | Available |
| MC20200-C0 | — | MR Unsafe | Available |
| MC20200-K0 | — | MR Unsafe | Available |
| MC20250-00 | — | MR Unsafe | Available |
| MC20250-K0 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K172344 November 2017
Procedures that use biopsy needles
Frequently asked questions
What is Medcut 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 Medcut?
Medcut is made by Medax Srl Unipersonale. It is listed under biopsy needles and systems in our device library.
What sizes does Medcut come in?
The FDA device database does not list sizes for Medcut. Check the instructions for use or ask a Medax Srl Unipersonale representative.
Is Medcut MRI safe?
The FDA device database lists Medcut as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Medcut FDA cleared?
Medcut is covered by FDA submission K172344.
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.