Cleared Traditional

K934559 - KARL STORZ XENON LIGHT SOURCE MODEL 201...

K934559 is the FDA 510(k) clearance for KARL STORZ XENON LIGHT SOURCE MODEL 201... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCT) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K934559 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
218d
Days
Class 2
Risk

K934559 is an FDA 510(k) clearance for the KARL STORZ XENON LIGHT SOURCE MODEL 201320-20. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 22, 1994 after a review of 218 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology 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 K934559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1993
Decision Date April 22, 1994
Days to Decision 218 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 130d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCT Light Source, Endoscope, Xenon Arc
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCT Light Source, Endoscope, Xenon Arc

All 18
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K934559.
XENON LIGHT SOURCE MODEL 5121
K952696 · Richard Wolf Medical Instruments Corp. · Jul 1995
MODEL 5135 AUTO LP/FLASH
K944607 · Richard Wolf Medical Instruments Corp. · Dec 1994
MODEL 5151
K944821 · Richard Wolf Medical Instruments Corp. · Nov 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270 · Welch Allyn, Inc. · Apr 1994
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
K936198 · Carl Zeiss, Inc. · Apr 1994
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · Medical Devices, Inc. · Jul 1993