Biopsy needles
Mammotome elite
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 elite 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 |
|---|---|---|---|
| CA000687001 | — | Not stated | Available |
| DIRECT MARK | — | Not stated | Available |
| MEH1 | — | Not stated | Available |
FDA clearances
- 510(k) K153709 August 2016
Procedures that use biopsy needles
Frequently asked questions
What is Mammotome elite 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 elite?
Mammotome elite is made by Devicor Medical Products, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Mammotome elite come in?
The FDA device database does not list sizes for Mammotome elite. Check the instructions for use or ask a Devicor Medical Products, Inc. representative.
Is Mammotome elite MRI safe?
The FDA device database entry for Mammotome elite does not state its MRI safety status. Check the labeling before MRI.
Is Mammotome elite FDA cleared?
Mammotome elite is covered by FDA submission K153709.
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.