Cleared Traditional

ESSENTIAL SHAVER SYSTEM (K974232) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K974232 · Gyrus Ent LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
61d
Days
Class 1
Risk

K974232 is an FDA 510(k) clearance for the ESSENTIAL SHAVER SYSTEM. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on January 12, 1998 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gyrus Ent LLC devices

Submission Details

510(k) Number K974232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date January 12, 1998
Days to Decision 61 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 89d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
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.

Regulatory Peers - EQJ Bur, Ear, Nose And Throat

All 17
Devices cleared under the same product code (EQJ) and FDA review panel - the closest regulatory comparables to K974232.
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