Cleared Traditional

K150169 - Sertera Biopsy Device

K150169 is an FDA 510(k) clearance for Sertera Biopsy Device, manufactured by Hologic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K150169 · Hologic, Inc. · Gastroenterology & Urology device
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Aug 2015
Decision
200d
Days
Class 2
Risk

K150169 is an FDA 510(k) clearance for the Sertera Biopsy Device. 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 14, 2015 after a review of 200 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K150169

510(k) Number K150169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2015
Decision Date August 14, 2015
Days to Decision 200 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
69d slower than avg
Panel avg: 131d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 215
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K150169.
Mammotome revolve Dual Vacuum Assist Biopsy System
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Imbibe Needle
K153306 · Orthovita, Inc. · Dec 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · Care Fusion · Sep 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014