Biopsy needles
Mammotome Revolve EX Holster
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 EX Holster 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 |
|---|---|---|---|
| MHEXH1 | — | Not stated | Available |
FDA clearances
- 510(k) K202012 August 2020
Procedures that use biopsy needles
Frequently asked questions
What is Mammotome Revolve EX Holster 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 EX Holster?
Mammotome Revolve EX Holster is made by Devicor Medical Products, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Mammotome Revolve EX Holster come in?
The FDA device database does not list sizes for Mammotome Revolve EX Holster. Check the instructions for use or ask a Devicor Medical Products, Inc. representative.
Is Mammotome Revolve EX Holster MRI safe?
The FDA device database entry for Mammotome Revolve EX Holster does not state its MRI safety status. Check the labeling before MRI.
Is Mammotome Revolve EX Holster FDA cleared?
Mammotome Revolve EX Holster is covered by FDA submission K202012.
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.