Cleared Traditional

DISPOSABLE ARACHNOID KNIFE

K882422 · Microbio-Medics, Inc. · Neurology
Sep 1988
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K882422 is an FDA 510(k) clearance for the DISPOSABLE ARACHNOID KNIFE, a Instrument, Surgical, Non-powered (Class I — General Controls, product code HAO), submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on September 6, 1988, 85 days after receiving the submission on June 13, 1988. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4535.

Submission Details

510(k) Number K882422 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1988
Decision Date September 06, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HAO — Instrument, Surgical, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4535

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