EnCor EnCompass Breast Biopsy and Tissue Removal System— 510(k) K262571

Name: FDA 510(k) clearance K262571
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K262571 for EnCor EnCompass Breast Biopsy and Tissue Removal System, Substantially Equivalent on 2026-08-14. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2026-07-24
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

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K260517 — Automatic Core Biopsy Instrument2026-08-28
K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
K260572 — Marrow Marxman2026-08-04
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12
K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more2026-03-04

More clearances from Bard Peripheral Vascular, Inc.

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K260012 — UltraScore Focused Force PTA Balloon2026-02-04
K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System2025-12-12
K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit2025-07-10
K250219 — Dorado PTA Balloon Dilatation Catheter2025-06-17
K243642 — UltraCor Twirl Breast Tissue Marker2025-03-24

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.