510(k) K962595

KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS by KARL STORZ Endoscopy-America, Inc. — Product Code FFS

K962595 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS". The FDA issued a decision of Substantially Equivalent on September 4, 1996. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), 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.