Cleared Traditional

K942403 - INFUSION CANNULA

K942403 is the FDA 510(k) clearance for INFUSION CANNULA by Microsurgical Technology, Inc.. It is a Class 1 Ophthalmic device (product code HMX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K942403 · Microsurgical Technology, Inc. · Ophthalmic device
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Aug 1994
Decision
90d
Days
Class 1
Risk

K942403 is an FDA 510(k) clearance for the INFUSION CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Microsurgical Technology, Inc. devices

Submission Details

510(k) Number K942403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date August 17, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 38
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K942403.
VITREORETINAL INFUSION CANNULA
K904074 · Visitec Co. · Feb 1991
STORZ INFUSION CANNULA
K882884 · Storz Instrument Co. · Aug 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
K874969 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
K874970 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS
K874971 · Advanced Surgical Products, Inc. · Apr 1988