Cleared Special

K262792 - Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)

K262792 is an FDA 510(k) clearance for Brevera Biopsy System with CorLumina Im..., manufactured by Hologic, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Special 510(k) pathway after a 6-day FDA review.

K262792 · Hologic, Inc. · General & Plastic Surgery device
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Aug 2026
Decision
6d
Days
Class 2
Risk

K262792 is an FDA 510(k) clearance for the Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on August 12, 2026 after a review of 6 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 Hologic, Inc. devices

FDA 510(k) Submission Details - K262792

510(k) Number K262792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2026
Decision Date August 12, 2026
Days to Decision 6 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
109d faster than avg
Panel avg: 115d · This submission: 6d
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 K262792.
Automatic Core Biopsy Instrument
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Marrow Marxman
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Promisemed VeriEcto Automatic Biopsy Needles
K261196 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
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ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026