Cleared Traditional

K931398 - GM SWIVEL VIDEO (TM) IRRIGATOR

K931398 is an FDA 510(k) clearance for GM SWIVEL VIDEO (TM) IRRIGATOR, manufactured by Gm Engineering, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KAR cleared through the Traditional 510(k) pathway after a 164-day FDA review.

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

FDA 510(k) Submission Details - K931398

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.

KAR Device Classification - Class 1, General Controls

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.