Cleared Traditional

K936050 - JAW SPREADER

K936050 is an FDA 510(k) clearance for JAW SPREADER, manufactured by Gam Industries, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KBW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K936050 · Gam Industries, Inc. · Ear, Nose, Throat device
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Mar 1994
Decision
94d
Days
Class 1
Risk

K936050 is an FDA 510(k) clearance for the JAW SPREADER. Classified as Screw, Oral (product code KBW), Class I - General Controls.

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on March 24, 1994 after a review of 94 days - within the typical 510(k) review window.

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 Gam Industries, Inc. devices

FDA 510(k) Submission Details - K936050

510(k) Number K936050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date March 24, 1994
Days to Decision 94 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
4d slower than avg
Panel avg: 90d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

KBW Device Classification - Class 1, General Controls

Product Code KBW Screw, Oral
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.