Cleared Traditional

K930123 - ASPIRATING ENDO OCULAR PROBE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K930123 · Surgical Technologies, Inc. · Ear, Nose, Throat device
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Feb 1994
Decision
400d
Days
Class 1
Risk

K930123 is an FDA 510(k) clearance for the ASPIRATING ENDO OCULAR PROBE. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Surgical Technologies, Inc. (Chesterfield, US). The FDA issued a Cleared decision on February 16, 1994 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - the FDA ear, nose and throat 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Technologies, Inc. devices

Submission Details

510(k) Number K930123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date February 16, 1994
Days to Decision 400 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 89d · This submission: 400d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.