Cleared Traditional

K003699 - MEDIVISION IGS SYSTEM

K003699 is an FDA 510(k) clearance for MEDIVISION IGS SYSTEM, manufactured by Medivision (U.S.A.), Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K003699 · Medivision (U.S.A.), Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
88d
Days
Class 2
Risk

K003699 is an FDA 510(k) clearance for the MEDIVISION IGS SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medivision (U.S.A.), Inc. (West Chester, US). The FDA issued a Cleared decision on February 27, 2001 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medivision (U.S.A.), Inc. devices

FDA 510(k) Submission Details - K003699

510(k) Number K003699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2000
Decision Date February 27, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 327
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K003699.
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