510(k) K962881

KSEA CULDOCENTESIS SET by Karl Storz Endoscopy — Product Code HEW

K962881 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "KSEA CULDOCENTESIS SET". The FDA issued a decision of Substantially Equivalent on October 22, 1996. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.