Cleared Traditional

K933527 - MODIFICATION OF ANTERIOR SEGMENT ELECTRODES

K933527 is an FDA 510(k) clearance for MODIFICATION OF ANTERIOR SEGMENT ELECTRODES, manufactured by Mira, Inc.. The device is a Class 1 Orthopedic device with product code HWA cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K933527

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

HWA Device Classification - Class 1, General Controls

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.