Cleared Traditional

K982570 - SNN SCOUT

K982570 is an FDA 510(k) clearance for SNN SCOUT, manufactured by I.S.G. Technologies, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K982570 · I.S.G. Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
174d
Days
Class 2
Risk

K982570 is an FDA 510(k) clearance for the SNN SCOUT. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on January 13, 1999 after a review of 174 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 I.S.G. Technologies, Inc. devices

FDA 510(k) Submission Details - K982570

510(k) Number K982570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1998
Decision Date January 13, 1999
Days to Decision 174 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
26d slower than avg
Panel avg: 148d · This submission: 174d
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 278
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K982570.
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K983397 · Surgical Navigation Technologies, Inc. · Dec 1998
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