510(k) K993625

INSUFFLATION NEEDLE- 120MM, MODEL 900-200 by Genicon, LC — Product Code HIF

K993625 is an FDA 510(k) premarket notification submitted by Genicon, LC for the device "INSUFFLATION NEEDLE- 120MM, MODEL 900-200". The FDA issued a decision of Substantially Equivalent on June 20, 2000. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Genicon, LC has at least 5 other 510(k) clearances on record.