Cleared Traditional

K001642 - INSIGHT IMAGE GUIDED SURGICAL SYSTEM

K001642 is an FDA 510(k) clearance for INSIGHT IMAGE GUIDED SURGICAL SYSTEM, manufactured by Surgical Insights, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K001642 · Surgical Insights, Inc. · Neurology device
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Sep 2000
Decision
105d
Days
Class 2
Risk

K001642 is an FDA 510(k) clearance for the INSIGHT IMAGE GUIDED SURGICAL SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Surgical Insights, Inc. (Evanston, US). The FDA issued a Cleared decision on September 12, 2000 after a review of 105 days - within the typical 510(k) review window.

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 Surgical Insights, Inc. devices

FDA 510(k) Submission Details - K001642

510(k) Number K001642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date September 12, 2000
Days to Decision 105 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
43d faster than avg
Panel avg: 148d · This submission: 105d
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 332
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K001642.
STRYKER REMOTE SURGICAL PLANNING SYSTEM
K004027 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · Image-Guided Neurologics, Inc. · Jun 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · Radionics, Inc. · May 2000