Biopsy needles
Mammotome Revolve
by Devicor Medical Products, Inc.
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Mammotome Revolve 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 |
|---|---|---|---|
| CA00006003 | — | Not stated | Available |
| CA000507001 | — | Not stated | Available |
| DIRECT MARK | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| MCART1 | — | Not stated | Available |
| MFOOT1 | — | Not stated | Available |
| MHKEYP1 | — | Not stated | Available |
| MHUSH1 | — | Not stated | Available |
| MSCM1 | — | Not stated | Available |
| MSCM1 | — | Not stated | Available |
| MSTH1 | — | Not stated | Available |
FDA clearances
- 510(k) K152989 February 2016
Procedures that use biopsy needles
Frequently asked questions
What is Mammotome Revolve used for?
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Who makes Mammotome Revolve?
Mammotome Revolve is made by Devicor Medical Products, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Mammotome Revolve come in?
The FDA device database does not list sizes for Mammotome Revolve. Check the instructions for use or ask a Devicor Medical Products, Inc. representative.
Is Mammotome Revolve MRI safe?
The FDA device database entry for Mammotome Revolve does not state its MRI safety status. Check the labeling before MRI.
Is Mammotome Revolve FDA cleared?
Mammotome Revolve is covered by FDA submission K152989.
How do I contact a Devicor Medical Products, Inc. sales representative?
Devicor Medical Products, Inc. has not listed representatives on LA Vascular yet. Visit the Devicor Medical Products, Inc. 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.