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FDA 510(k)

EnCor EnCompass™ Breast Biopsy and Tissue Removal System

K-Number: K262571 · 2026-08-14

ApplicantBard Peripheral Vascular, Inc.
Decision Date2026-08-14
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EnCor EnCompass™ Breast Biopsy and Tissue Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K262571. 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 2026-08-14. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K262571.

When did EnCor EnCompass™ Breast Biopsy and Tissue Removal System receive FDA 510(k) clearance?

EnCor EnCompass™ Breast Biopsy and Tissue Removal System received FDA 510(k) clearance on 2026-08-14, under 510(k) number K262571.

Who is the listed applicant for EnCor EnCompass™ Breast Biopsy and Tissue Removal System?

The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05437757Scaffold-guided Breast SurgeryCOMPLETEDNCT05975359Assessment of the Interi Manifold in Implant-Based Breast ReconstructionRECRUITINGNCT06306638Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway ObstructionRECRUITINGNCT07367698Scaffold-guided Breast Implant Revision and Primary Breast Augmentation SurgeryRECRUITINGNCT07527468HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving SurgeryNOT_YET_RECRUITINGNCT07607366Effects of Negative Pressure Wound Bandaging After MastectomyRECRUITING

Other records listing Bard Peripheral Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P130029System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentPMA P180037Stent, iliac veinPMA P070014STENT, SUPERFICIAL FEMORAL ARTERYK260012UltraScore™ Focused Force PTA BalloonK252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemPMA P160024Iliac covered stent, arterial

View all 26 devices →

Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, 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.

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