510(k) K910883

LAPAROFLATOR ELECTRONIC 3509 by F.M. Wiest USA, Inc. — Product Code HIF

K910883 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "LAPAROFLATOR ELECTRONIC 3509". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. F.M. Wiest USA, Inc. has at least 10 other 510(k) clearances on record.