Cleared Traditional

K182417 - ROSA ONE Brain Application

K182417 is an FDA 510(k) clearance for ROSA ONE Brain Application, manufactured by Medtech S.A. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K182417 · Medtech S.A · Neurology device
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Feb 2019
Decision
155d
Days
Class 2
Risk

K182417 is an FDA 510(k) clearance for the ROSA ONE Brain Application. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtech S.A (Montpellier, FR). The FDA issued a Cleared decision on February 7, 2019 after a review of 155 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtech S.A devices

FDA 510(k) Submission Details - K182417

510(k) Number K182417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2018
Decision Date February 07, 2019
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 148d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 331
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K182417.
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