Cleared Traditional

THE NEW MOBILE TIP MCINTYRE CANNULA

K854401 · Microsurgical Technology, Inc. · Ophthalmic
Dec 1985
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K854401 is an FDA 510(k) clearance for the THE NEW MOBILE TIP MCINTYRE CANNULA, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 30, 1985, 60 days after receiving the submission on October 31, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K854401 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1985
Decision Date December 30, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HMX — Cannula, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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