510(k) K800397

ELLIK BLADDER EVACUATOR by Sage Products, Inc. — Product Code KQT

K800397 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "ELLIK BLADDER EVACUATOR". The FDA issued a decision of Substantially Equivalent on March 10, 1980. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. Sage Products, Inc. has at least 10 other 510(k) clearances on record.