Cleared Traditional

K963642 - INCL II ENDOSCOPE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963642 · Sofamor Danek USA,Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
552d
Days
Class 2
Risk

K963642 is an FDA 510(k) clearance for the INCL II ENDOSCOPE. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on March 18, 1998 after a review of 552 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Sofamor Danek USA,Inc. devices

Submission Details

510(k) Number K963642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date March 18, 1998
Days to Decision 552 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
404d slower than avg
Panel avg: 148d · This submission: 552d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GWG Endoscope, Neurological

All 90
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