510(k) K010510

BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 by A & A Medical, Inc. — Product Code HET

K010510 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.