Cleared Traditional

CLARUS ENDOSCOPIC BALL PROBE

K926048 · Clarus Medical Systems, Inc. · Neurology
Apr 1993
Decision
127d
Days
Class 1
Risk

About This 510(k) Submission

K926048 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC BALL PROBE, a Instrument, Microsurgical (Class I — General Controls, product code GZX), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 7, 1993, 127 days after receiving the submission on December 1, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4525.

Submission Details

510(k) Number K926048 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GZX — Instrument, Microsurgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4525

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