Cleared Traditional

MICRA MICROSURGICAL INSTRUMENTS

K862971 · Cordis Corp. · Neurology
Aug 1986
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K862971 is an FDA 510(k) clearance for the MICRA MICROSURGICAL INSTRUMENTS, a Instrument, Microsurgical (Class I — General Controls, product code GZX), submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on August 25, 1986, 19 days after receiving the submission on August 6, 1986. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4525.

Submission Details

510(k) Number K862971 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1986
Decision Date August 25, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

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

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