510(k) K921015

SHARPE ENDOSPONGE ASPIIRATOR by Paladin Medical, Inc. — Product Code HET

K921015 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "SHARPE ENDOSPONGE ASPIIRATOR". The FDA issued a decision of Substantially Equivalent on May 21, 1993. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.