Cleared Traditional

GM SWIVEL VIDEO (TM) IRRIGATOR (K931398) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K931398 · Gm Engineering, Inc. · Ear, Nose, Throat device
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Aug 1993
Decision
164d
Days
Class 1
Risk

K931398 is an FDA 510(k) clearance for the GM SWIVEL VIDEO (TM) IRRIGATOR. Classified as Irrigator, Sinus (product code KAR), Class I - General Controls.

Submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on August 30, 1993 after a review of 164 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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. Standard predicate reliance. 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 Gm Engineering, Inc. devices

Submission Details

510(k) Number K931398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1993
Decision Date August 30, 1993
Days to Decision 164 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
75d slower than avg
Panel avg: 89d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAR Irrigator, Sinus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.