510(k) K954982

KSEA SCALP BLOOD COLLECTION SET by KARL STORZ Endoscopy-America, Inc. — Product Code HGK

K954982 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA SCALP BLOOD COLLECTION SET". The FDA issued a decision of Substantially Equivalent on July 17, 1996. The device falls under product code HGK (Endoscope, Fetal Blood Sampling (And Accessories)), a Class II device regulated under 21 CFR 884.1660. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.