510(k) K875137

LAPAROFLATOR 3000, STANDARD AND ELECTRONIC by F.M. Wiest USA, Inc. — Product Code HES

K875137 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "LAPAROFLATOR 3000, STANDARD AND ELECTRONIC". The FDA issued a decision of Substantially Equivalent on March 2, 1988. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. F.M. Wiest USA, Inc. has at least 10 other 510(k) clearances on record.