Cleared Traditional

K833608 - GOLD ALLIGATOR FORCEPS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K833608 · Microtek Medical, Inc. · Ear, Nose, Throat device
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Jan 1984
Decision
91d
Days
Class 1
Risk

K833608 is an FDA 510(k) clearance for the GOLD ALLIGATOR FORCEPS. Classified as Forceps, Ent (product code KAE), Class I - General Controls.

Submitted by Microtek Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 91 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 Microtek Medical, Inc. devices

Submission Details

510(k) Number K833608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 11, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 89d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAE Forceps, Ent
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.