510(k) K946380

NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) by American Hydro-Surgical Instruments, Inc. — Product Code HET

K946380 is an FDA 510(k) premarket notification submitted by American Hydro-Surgical Instruments, Inc. for the device "NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)". The FDA issued a decision of Substantially Equivalent on July 6, 1995. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. American Hydro-Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.