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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.
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".
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.
Query for this technology: (TITLE:"Vacuum-assisted breast biopsy systems" OR ABSTRACT:"Vacuum-assisted breast biopsy systems" OR TITLE:"Mammotome, EnCor, Eviva, Brevera" OR ABSTRACT:"Mammotome, EnCor, Eviva, Brevera" OR TITLE:"Vacuum-assisted biopsy" OR ABSTRACT:"Vacuum-assisted biopsy" OR TITLE:"Vacuum-assisted excision" OR ABSTRACT:"Vacuum-assisted excision") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Vacuum-assisted breast biopsy systems (Mammotome, EnCor, Eviva, Brevera), not a curated reading list.
Shares Breast lesion localisation markers (wire, magnetic seed, radar reflector, RFID tag), Mammotome (Danaher), Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares BD (Becton, Dickinson and Company), Core needle biopsy and fine-needle aspiration (FNA), Biopsy and the tag devices-gaps-2026-11.
Shares BD (Becton, Dickinson and Company) and the tag devices-gaps-2026-11.
Shares BD (Becton, Dickinson and Company) and the tag devices-gaps-2026-11.
Shares BD (Becton, Dickinson and Company), Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares BD (Becton, Dickinson and Company), Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares BD (Becton, Dickinson and Company) and the tag devices-gaps-2026-11.
Shares Biopsy and the tag devices-gaps-2026-11.
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