510(k) K960936

RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] by Origin Medsystems, Inc. — Product Code HET

K960936 is an FDA 510(k) premarket notification submitted by Origin Medsystems, Inc. for the device "RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]". The FDA issued a decision of Substantially Equivalent on July 24, 1996. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Origin Medsystems, Inc. has at least 10 other 510(k) clearances on record.