Cleared Traditional

K172344 - Medax Biopsy Systems II (MEDONE

K172344 is the FDA 510(k) clearance for Medax Biopsy Systems II (MEDONE by Medax Srl Unipersonale. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K172344 · Medax Srl Unipersonale · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
103d
Days
Class 2
Risk

K172344 is an FDA 510(k) clearance for the Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Medax Srl Unipersonale (Poggio Rusco, IT). The FDA issued a Cleared decision on November 13, 2017 after a review of 103 days - within the typical 510(k) review window.

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 Medax Srl Unipersonale devices

Submission Details

510(k) Number K172344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date November 13, 2017
Days to Decision 103 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 130d · This submission: 103d
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 161
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K172344.
Eviva Stereotactic Guided Breast Biopsy System
K180233 · Hologic, Inc. · Apr 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
Bard Mission Disposable Core Biopsy Instrument
K171953 · Bard Peripheral Vascular, Inc. · Sep 2017
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
K171531 · Care Fusion · Sep 2017