510(k) K993804

KSEA RIGID CULDOSCOPE AND ACCESSORIES by KARL STORZ Endoscopy-America, Inc. — Product Code HEW

K993804 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA RIGID CULDOSCOPE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 7, 2000. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.