510(k) K022052

40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 by Northgate Technologies, Inc. — Product Code HIF

K022052 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0". The FDA issued a decision of Substantially Equivalent on January 24, 2003. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.