Cleared Special

K262571 - EnCor EnCompass™ Breast Biopsy and Tissue Removal System

K262571 is an FDA 510(k) clearance for EnCor EnCompass Breast Biopsy and Tissu..., manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Special 510(k) pathway after a 21-day FDA review.

K262571 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
21d
Days
Class 2
Risk

K262571 is an FDA 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on August 14, 2026 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K262571

510(k) Number K262571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2026
Decision Date August 14, 2026
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 255
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K262571.
Automatic Core Biopsy Instrument
K260517 · Zhejiang Curaway Medical Technology Co., Ltd. · Aug 2026
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
K262792 · Hologic, Inc. · Aug 2026
Marrow Marxman
K260572 · Medimetrix, LLC · Aug 2026
Promisemed VeriEcto Automatic Biopsy Needles
K261196 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · Devicor Medical Products, Inc. · Mar 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026