Cleared Traditional

CLARUS ENDOSCOPIC HOOK KNIFE

K925741 · Clarus Medical Systems, Inc. · Ophthalmic
Aug 1993
Decision
284d
Days
Class 2
Risk

About This 510(k) Submission

K925741 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC HOOK KNIFE, a Photostimulator, Ac-powered (Class II — Special Controls, product code HLX), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 24, 1993, 284 days after receiving the submission on November 13, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number K925741 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1992
Decision Date August 24, 1993
Days to Decision 284 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLX — Photostimulator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1630

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