Cleared Traditional

K142125 - New Medax Biopsy Systems

K142125 is an FDA 510(k) clearance for New Medax Biopsy Systems, manufactured by Medax Srl Unipersonale. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 505-day FDA review.

K142125 · Medax Srl Unipersonale · Gastroenterology & Urology device
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Dec 2015
Decision
505d
Days
Class 2
Risk

K142125 is an FDA 510(k) clearance for the New Medax Biopsy Systems. 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 December 22, 2015 after a review of 505 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medax Srl Unipersonale devices

FDA 510(k) Submission Details - K142125

510(k) Number K142125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date December 22, 2015
Days to Decision 505 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 131d · This submission: 505d
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 Consultant

Coronati Consutling Sas
SERENA CORONATI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNW Instrument, Biopsy

All 290
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