Biopsy needles
Mammotome
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 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 |
|---|---|---|---|
| DIRECT MARK GTIN | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| DIRECT MARK GTIN | — | Not stated | Available |
| HHEX | — | Not stated | Available |
| MFSW1 | — | Not stated | Available |
| MFSW1 | — | Not stated | Available |
| MKEY1 | — | Not stated | Available |
| MRH1 | — | Not stated | Available |
| MRLB1 | — | Not stated | Available |
| SCM12 | — | Not stated | Available |
| SCM23 | — | Not stated | Available |
| SCMC1 | — | Not stated | Available |
| SCMC3 | — | Not stated | Available |
| SCMSW6 | — | Not stated | Available |
| SCMSW6 | — | Not stated | Available |
| STCH1 | — | Not stated | Available |
| STHC1 | — | Not stated | Available |
| VAS08 | Needle Gauge 8 G | Not stated | Available |
| VAS11 | Needle Gauge 11 G | Not stated | Available |
FDA clearances
- 510(k) K042753 November 2004
- 510(k) K033700 February 2004
- 510(k) K991980 August 1999
Procedures that use biopsy needles
Frequently asked questions
What is Mammotome 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?
Mammotome is made by Devicor Medical Products, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Mammotome come in?
Sizes listed for Mammotome: Needle Gauge: 8–11 G. Confirm availability with the manufacturer's instructions for use.
Is Mammotome MRI safe?
The FDA device database entry for Mammotome does not state its MRI safety status. Check the labeling before MRI.
Is Mammotome FDA cleared?
Mammotome is covered by FDA submissions K042753, K991980, K033700.
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.