# Vacuum-assisted breast biopsy systems (Mammotome, EnCor, Eviva, Brevera)

Source: https://onco.cc/technologies/vacuum-assisted-breast-biopsy/  
OnCo record `vacuum-assisted-breast-biopsy` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A breast biopsy needle that uses suction to pull tissue into its side window and cut it, so several larger samples can be taken through one small cut in the skin, guided by mammogram, ultrasound or MRI.

## Summary

Breast biopsy instruments are FDA product code KNW (21 CFR 876.1075). Vacuum-assisted systems cleared in the database include Devicor's Mammotome Revolve dual vacuum-assisted biopsy system (K202012, 18 August 2020) and Mammotome Prima MR for MRI-guided biopsy (K260365, 4 March 2026), the EnCor Enspire breast biopsy system (Senorx, K233220, 27 October 2023) and EnCor EnCompass biopsy and tissue removal system (Bard Peripheral Vascular, K252681, 12 December 2025), Bard's EleVation driver and probes (K192948, 7 November 2019), Hologic's Eviva stereotactic system (K180233, 10 April 2018) and Hologic's Brevera with CorLumina imaging (K163052, 29 March 2017; updated K262792, 12 August 2026), which images each core as it is taken. The Mammotome Revolve summary states that it provides breast tissue "for histologic examination with partial or complete removal of the imaged abnormality" and warns that "the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy".

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-11-04
- Also known as: Vacuum-assisted biopsy; VAB; Vacuum-assisted excision; Mammotome Revolve; Mammotome Prima MR; EnCor Enspire; EnCor EnCompass; Eviva; EleVation; Brevera
- Tags: devices-gaps-2026-11
- Principle: A hollow probe with a side aperture is placed beside the lesion under imaging; vacuum draws tissue into the aperture, a rotating or oscillating inner cutter severs it, and the core is carried back to a collection chamber without withdrawing the probe.
- Since: 2017
- Strengths: Larger and more numerous cores through one skin entry; Works with stereotactic, tomosynthesis, ultrasound or MRI guidance
- Limitations: Bruising and haematoma; Removing the imaged lesion does not mean a cancer has been removed with clear margins

## Sources

- FDA product code KNW: biopsy instrument: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KNW
- FDA 510(k) K202012: Mammotome Revolve (18 August 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202012
- FDA 510(k) K260365: Mammotome Prima MR (4 March 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260365
- FDA 510(k) K233220: EnCor Enspire (27 October 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233220
- FDA 510(k) K252681: EnCor EnCompass (12 December 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252681
- FDA 510(k) K192948: EleVation breast biopsy driver (7 November 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192948
- FDA 510(k) K180233: Eviva stereotactic guided breast biopsy system (10 April 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180233
- FDA 510(k) K163052: Brevera with CorLumina imaging (29 March 2017): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163052
- FDA 510(k) K262792: Brevera with CorLumina imaging (12 August 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262792

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Imaging](https://onco.cc/fronts/imaging/)
- technologies: [Automated breast ultrasound (Invenia ABUS) and ultrasound tomography (SoftVue)](https://onco.cc/technologies/automated-breast-ultrasound/), [Breast lesion localisation markers (wire, magnetic seed, radar reflector, RFID tag)](https://onco.cc/technologies/breast-lesion-localisation/), [Breast MRI coils and abbreviated breast MRI](https://onco.cc/technologies/breast-mri-coils-abbreviated-mri/), [Mammography & tomosynthesis](https://onco.cc/technologies/mammography/), [Stereotactic and tomosynthesis-guided breast biopsy systems (Affirm, Giotto, Fujifilm positioner)](https://onco.cc/technologies/stereotactic-breast-biopsy/)
- companies: [BD (Becton, Dickinson and Company)](https://onco.cc/companies/becton-dickinson/), [Hologic](https://onco.cc/companies/hologic/), [Mammotome (Danaher)](https://onco.cc/companies/mammotome/)
- terms: [Biopsy](https://onco.cc/terms/biopsy/), [Core needle biopsy and fine-needle aspiration (FNA)](https://onco.cc/terms/core-needle-biopsy/)

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