Biopsy needles
EnCor
by Senorx, 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.
EnCor 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 |
|---|---|---|---|
| CM3000 | — | Not stated | Available |
| DRENCOR | — | Not stated | Available |
| DRENCORMR | — | MR Conditional | Available |
| ECCOAXCAN10G | — | Not stated | Available |
| ECCOAXCAN12G | — | Not stated | Available |
| ECMRINTLOC | — | Not stated | Available |
| ECMRINTLOC7G | — | Not stated | Available |
| ECTRACOVER | — | Not stated | Available |
| ECTT | — | Not stated | Available |
| ENCARINSERTMR10G | — | Not stated | Available |
| ENCFF01 | — | Not stated | Available |
| ENCFF02 | — | Not stated | Available |
| ENCFINSERT7G | — | Not stated | Available |
| ENCFINSERT10G | — | Not stated | Available |
| ENCFINSERT12G | — | Not stated | Available |
| ENCFNGUIDE01 | — | Not stated | Available |
| ENCLRINSERT7G | — | Not stated | Available |
| ENCLRINSERT10G | — | Not stated | Available |
| ENCLRINSERT12G | — | Not stated | Available |
| FSENCOR01 | — | Not stated | Available |
| FSENCORMR | — | MR Conditional | Available |
| RINSETUB | — | Not stated | Available |
| SCCAN01 | — | Not stated | Available |
| SCTUB3000 | — | Not stated | Available |
| SCVACPAK3000 | — | Not stated | Available |
| VACTUBEXT | — | Not stated | Available |
| VS3000 | — | Not stated | Available |
FDA clearances
- 510(k) K161805 July 2016
Procedures that use biopsy needles
Frequently asked questions
What is EnCor 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 EnCor?
EnCor is made by Senorx, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does EnCor come in?
The FDA device database does not list sizes for EnCor. Check the instructions for use or ask a Senorx, Inc. representative.
Is EnCor MRI safe?
The FDA device database entry for EnCor does not state its MRI safety status. Check the labeling before MRI.
Is EnCor FDA cleared?
EnCor is covered by FDA submission K161805.
How do I contact a Senorx, Inc. sales representative?
Senorx, Inc. has not listed representatives on LA Vascular yet. Visit the Senorx, 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.