Cleared Traditional

K953370 - KARL STORZ ENT SHAVER

K953370 is an FDA 510(k) clearance for KARL STORZ ENT SHAVER, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQJ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K953370 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
50d
Days
Class 1
Risk

K953370 is an FDA 510(k) clearance for the KARL STORZ ENT SHAVER. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 6, 1995 after a review of 50 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K953370

510(k) Number K953370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1995
Decision Date September 06, 1995
Days to Decision 50 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 90d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

EQJ Device Classification - Class 1, General Controls

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 10
Devices cleared under the same product code (EQJ) and FDA review panel - the closest regulatory comparables to K953370.
ESSENTIAL SHAVER SYSTEM
K974232 · Gyrus Ent LLC · Jan 1998
ACE SYSTEM
K960853 · Xomed, Inc. · Apr 1996
TREBAY MICRODEBRIDER SYSTEM
K955704 · Trebay Medical Corp. · Jan 1996
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
K950337 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
ESSENTIAL SHAVER SYSTEM
K953096 · Smith & Nephew Richards, Inc. · Jul 1995
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
K946332 · KARL STORZ Endoscopy-America, Inc. · Jun 1995