Cleared Traditional

Eviva Stereotactic Guided Breast Biopsy System (K180233) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180233 · Hologic, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
71d
Days
Class 2
Risk

K180233 is an FDA 510(k) clearance for the Eviva Stereotactic Guided Breast Biopsy System. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on April 10, 2018 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hologic, Inc. devices

Submission Details

510(k) Number K180233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date April 10, 2018
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 106
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K180233.
BEXCORE Breast Biopsy System, Biopsy Needle
K171890 · Medical Park Co., Ltd. · Aug 2018
SpeedBird Model SB38 Soft Tissue Biopsy Device
K173316 · Transmed7, LLC · Jun 2018
Celling Aspiration Needle
K180807 · Spine Smith Holdings, LLC · May 2018
Corvocet Biopsy System
K180450 · Merit Medical Systems, Inc. · Mar 2018
Stryker iVAS 13g Bone Biopsy Kit
K180327 · Stryker Corporation · Feb 2018
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
K172558 · Stryker Corporation · Oct 2017