Cleared Traditional

K914247 - ASPIRATING ENDO OCULAR PROBE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K914247 · Surgical Technologies, Inc. · Ear, Nose, Throat device
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Dec 1991
Decision
86d
Days
Class 1
Risk

K914247 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 December 18, 1991 after a review of 86 days - a notably fast clearance cycle.

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: 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 Surgical Technologies, Inc. devices

Submission Details

510(k) Number K914247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date December 18, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 89d · This submission: 86d
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.