510(k) K921837

MEDICAM 900 INSUFFLATOR WITH ACCESSORIES by Kirschner Medical Corp. — Product Code HIF

K921837 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "MEDICAM 900 INSUFFLATOR WITH ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.