Cleared Traditional

K192101 - Medone Ultra

K192101 is the FDA 510(k) clearance for Medone Ultra 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 241-day FDA review.

K192101 · Medax Srl Unipersonale · General & Plastic Surgery device
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Apr 2020
Decision
241d
Days
Class 2
Risk

K192101 is an FDA 510(k) clearance for the Medone Ultra, Medextra. 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 April 2, 2020 after a review of 241 days - an extended review cycle.

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 K192101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date April 02, 2020
Days to Decision 241 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 115d · This submission: 241d
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

Gemarmed S.R.L
Stefano Cavalieri

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 160
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K192101.
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · Devicor Medical Products, Inc. · Aug 2020
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
K201244 · Transmed7, LLC · Aug 2020
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
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CytoCore
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APrioCore Plus
K193268 · Apriomed AB · Feb 2020
EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
K192948 · Bard Peripheral Vascular, Inc. · Nov 2019