510(k) K955393

NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE by Surgical Innovations Plc — Product Code HIF

K955393 is an FDA 510(k) premarket notification submitted by Surgical Innovations Plc for the device "NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on January 9, 1997. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Surgical Innovations Plc has at least 9 other 510(k) clearances on record.