510(k) K882297

1/2 CM REAR TIP EXTENDER (RTE) by American Medical Systems, Inc. — Product Code FHN

K882297 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "1/2 CM REAR TIP EXTENDER (RTE)". The FDA issued a decision of Substantially Equivalent on June 17, 1988. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.