510(k) K914153

OTT INSUFFLATOR FILTER PLUS/TUBING SET by Marlo Surgical Technology — Product Code HIF

K914153 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "OTT INSUFFLATOR FILTER PLUS/TUBING SET". The FDA issued a decision of Substantially Equivalent on April 2, 1992. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.