510(k) K161554

ENDOFLATOR 40, ENDOFLATOR 50 by KARL STORZ Endoscopy-America, Inc. — Product Code HIF

K161554 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "ENDOFLATOR 40, ENDOFLATOR 50". The FDA issued a decision of Substantially Equivalent on Mar 2, 2017. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. KARL STORZ Endoscopy-America, Inc. has 333 other 510(k) clearances on record.