510(k) K082925

XENON-100 SCB LIGHT SOURCE, MODEL 20132620 by KARL STORZ Endoscopy-America, Inc. — Product Code GCT

K082925 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "XENON-100 SCB LIGHT SOURCE, MODEL 20132620". The FDA issued a decision of Substantially Equivalent on December 18, 2008. The device falls under product code GCT (Light Source, Endoscope, Xenon Arc), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.