Cleared Traditional

K082925 - XENON-100 SCB LIGHT SOURCE, MODEL 20132620

K082925 is an FDA 510(k) clearance for XENON-100 SCB LIGHT SOURCE, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K082925 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
78d
Days
Class 2
Risk

K082925 is an FDA 510(k) clearance for the XENON-100 SCB LIGHT SOURCE, MODEL 20132620. 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 December 18, 2008 after a review of 78 days - a notably fast clearance 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: 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 - K082925

510(k) Number K082925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date December 18, 2008
Days to Decision 78 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
53d faster than avg
Panel avg: 131d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCT Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K082925.
CONMED LINVATEC 300W XENON LIGHT SOURCE
K070376 · Conmed Linvatec · Aug 2007
KSEA MEDI PACK
K022490 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994 · Linvatec Corp. · Aug 2003
LUMENON XENON LIGHT SOURCE
K992050 · Walter Lorenz Surgical, Inc. · Sep 1999
XENON LIGHT SOURCE PES 1
K992540 · Laser Optik Systeme GmbH & Co. KG · Sep 1999
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · Richard Wolf Medical Instruments Corp. · Dec 1998