FDA 510(k)

EnCor EnCompass Breast Biopsy and Tissue Removal System

K-Number: K252681 · 2025-12-12

Decision Date2025-12-12

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EnCor EnCompass Breast Biopsy and Tissue Removal System is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-12-12 under approval number K252681. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnCor EnCompass Breast Biopsy and Tissue Removal System?

EnCor EnCompass Breast Biopsy and Tissue Removal System is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K252681.

When was EnCor EnCompass Breast Biopsy and Tissue Removal System approved by the FDA?

EnCor EnCompass Breast Biopsy and Tissue Removal System received FDA 510(k) clearance on 2025-12-12, under approval number K252681.

What company makes EnCor EnCompass Breast Biopsy and Tissue Removal System?

EnCor EnCompass Breast Biopsy and Tissue Removal System is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for EnCor EnCompass Breast Biopsy and Tissue Removal System?

The FDA product code for EnCor EnCompass Breast Biopsy and Tissue Removal System is KNW.

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Other Devices by Bard Peripheral Vascular, Inc.

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Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.