Cleared Traditional

K954910 - KARL STORZ OPTICAL MEDIASTINOSCOPE

K954910 is the FDA 510(k) clearance for KARL STORZ OPTICAL MEDIASTINOSCOPE by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EWY) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K954910 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
9d
Days
Class 2
Risk

K954910 is an FDA 510(k) clearance for the KARL STORZ OPTICAL MEDIASTINOSCOPE. Classified as Mediastinoscope, Surgical (product code EWY), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4720 - 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

Submission Details

510(k) Number K954910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1995
Decision Date November 03, 1995
Days to Decision 9 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
80d faster than avg
Panel avg: 89d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWY Mediastinoscope, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4720
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWY Mediastinoscope, Surgical

All 7
Devices cleared under the same product code (EWY) and FDA review panel - the closest regulatory comparables to K954910.
HD Mediastinoscope
K213194 · KARL STORZ Endoscopy-America, Inc. · Jun 2022
HD Mediastinoscope
K202272 · KARL STORZ Endoscopy-America, Inc. · May 2021
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
K971166 · Richard Wolf Medical Instruments Corp. · Aug 1997
FLEXIBLE TROCAR TUBES
K930215 · Olympus Corp. · Mar 1993
OLYMPUS FLEXIBLE TIP THORACOSCOPE
K913829 · Olympus Corp. · Nov 1991
OES THORACOSCOPE SYSTEM
K912362 · Olympus Corp. · Oct 1991