510(k) K000027

INSUFFLATION NEEDLE, MODEL R65-933 by A & A Medical, Inc. — Product Code HIF

K000027 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "INSUFFLATION NEEDLE, MODEL R65-933". The FDA issued a decision of Substantially Equivalent on April 3, 2000. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.