Cleared Traditional

K950337 - KARL STORZ STAMMBERGER-SACHSE INTRANASA...

K950337 is the FDA 510(k) clearance for KARL STORZ STAMMBERGER-SACHSE INTRANASA... by KARL STORZ Endoscopy-America, Inc.. It is a Class 1 Ear, Nose, Throat device (product code EQJ) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K950337 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
208d
Days
Class 1
Risk

K950337 is an FDA 510(k) clearance for the KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL. 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 August 23, 1995 after a review of 208 days - an extended review 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: 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K950337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date August 23, 1995
Days to Decision 208 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
119d slower than avg
Panel avg: 89d · This submission: 208d
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 7
Devices cleared under the same product code (EQJ) and FDA review panel - the closest regulatory comparables to K950337.
XPS CURVED BUR
K041985 · Medtronic Xomed, Inc. · Aug 2004
ACE SYSTEM
K960853 · Xomed, Inc. · Apr 1996
KARL STORZ ENT SHAVER
K953370 · KARL STORZ Endoscopy-America, Inc. · Sep 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
OTOTOME BUR
K792028 · American Sterilizer Co. · Oct 1979