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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 353
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K150169.
New Medax Biopsy Systems
K142125 · Medax Srl Unipersonale · Dec 2015
Imbibe Needle
K153306 · Orthovita, Inc. · Dec 2015
Avitus Bone Harvester
K152474 · Avitus Orthopaedics, Inc. · Oct 2015
Evacore Fully Disposable Vacuum Assist Biopsy Device
K150088 · Pin-Point Care Corp. · Jul 2015
Morrison Steerable Needle
K150625 · Apriomed AB · Jun 2015
Marrow Cellution Bone Marrow Aspiration Needle
K150563 · Ranfac, Corp. · May 2015
K150169 · Sertera Biopsy Device
Download PDF FDA Summary Hologic, Inc.