Cleared Traditional

K181803 - Medax Biopsy Systems III

K181803 is the FDA 510(k) clearance for Medax Biopsy Systems III by Medax Srl Unipersonale. It is a Class 2 General & Plastic Surgery device (product code KNW) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K181803 · Medax Srl Unipersonale · General & Plastic Surgery device
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Oct 2018
Decision
105d
Days
Class 2
Risk

K181803 is an FDA 510(k) clearance for the Medax Biopsy Systems III. 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 October 18, 2018 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medax Srl Unipersonale devices

Submission Details

510(k) Number K181803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2018
Decision Date October 18, 2018
Days to Decision 105 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Coronati Consulting Srl
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

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