510(k) K022490

KSEA MEDI PACK by KARL STORZ Endoscopy-America, Inc. — Product Code GCT

K022490 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA MEDI PACK". The FDA issued a decision of Substantially Equivalent on September 29, 2003. 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.