Cleared Traditional

K926048 - CLARUS ENDOSCOPIC BALL PROBE (FDA 510(k) Clearance)

Class I Neurology device.

K926048 · Clarus Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
127d
Days
Class 1
Risk

K926048 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC BALL PROBE. Classified as Instrument, Microsurgical (product code GZX), Class I - General Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4525 - 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 Clarus Medical Systems, Inc. devices

Submission Details

510(k) Number K926048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date April 07, 1993
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GZX Instrument, Microsurgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4525
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.