Cleared Traditional

STUDEX EAR PIERCING GUNS (K860622) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K860622 · Onyx Industries, Inc. · Ear, Nose, Throat device
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Oct 1986
Decision
240d
Days
Class 1
Risk

K860622 is an FDA 510(k) clearance for the STUDEX EAR PIERCING GUNS. Classified as Perforator, Ear-lobe (product code JYS), Class I - General Controls.

Submitted by Onyx Industries, Inc. (Harbor City, US). The FDA issued a Cleared decision on October 17, 1986 after a review of 240 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 Onyx Industries, Inc. devices

Submission Details

510(k) Number K860622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date October 17, 1986
Days to Decision 240 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
151d slower than avg
Panel avg: 89d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JYS Perforator, Ear-lobe
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.