Cleared Traditional

K853777 - THE NEW MCINTYRE CANNULA

K853777 is an FDA 510(k) clearance for THE NEW MCINTYRE CANNULA, manufactured by Microsurgical Technology, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K853777 · Microsurgical Technology, Inc. · Ophthalmic device
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Nov 1985
Decision
73d
Days
Class 1
Risk

K853777 is an FDA 510(k) clearance for the THE NEW MCINTYRE 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 November 21, 1985 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K853777

510(k) Number K853777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date November 21, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 110d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

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 76
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K853777.
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · Storz Instrument Co. · Feb 1986
THE NEW MOBILE TIP MCINTYRE CANNULA
K854401 · Microsurgical Technology, Inc. · Dec 1985
THE NEW MCINTYRE I.A. HANDPIECE
K854402 · Microsurgical Technology, Inc. · Dec 1985
INFUSION CANNULAM
K852758 · Precision Medical Instruments, Inc. · Aug 1985
SITE ANTERIOR CAPSULOTOMER
K843039 · Chiron Vision Corp. · Nov 1984
STERILIZED DISPOS. CYSTOTOME
K840442 · Microsurgical Technology, Inc. · Mar 1984
K853777 · THE NEW MCINTYRE CANNULA
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