Cleared Traditional

K933527 - MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (FDA 510(k) Clearance)

Class I Orthopedic device.

K933527 · Mira, Inc. · Orthopedic device
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Jan 1994
Decision
189d
Days
Class 1
Risk

K933527 is an FDA 510(k) clearance for the MODIFICATION OF ANTERIOR SEGMENT ELECTRODES. Classified as Impactor (product code HWA), Class I - General Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 189 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mira, Inc. devices

Submission Details

510(k) Number K933527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date January 25, 1994
Days to Decision 189 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWA Impactor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.