Cleared Traditional

K863664 - OPHTHALMIC SURGICAL SPECULUM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K863664 · Myocure, Inc. · Ophthalmic device
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Sep 1986
Decision
7d
Days
Class 1
Risk

K863664 is an FDA 510(k) clearance for the OPHTHALMIC SURGICAL SPECULUM. Classified as Specula, Ophthalmic (product code HNC), Class I - General Controls.

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 7 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.

View all Myocure, Inc. devices

Submission Details

510(k) Number K863664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date September 25, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 110d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNC Specula, 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.