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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 149d · 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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K001642.
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NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
K002053 · Orthosoft, Inc. · Aug 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001801 · Medtronic Surgical Navigation · Jun 2000
K001642 · INSIGHT IMAGE GUIDED SURGICAL SYSTEM
Download PDF FDA Summary Surgical Insights, In…