510(k) K860192

ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE by Endotherapeutics — Product Code HET

K860192 is an FDA 510(k) premarket notification submitted by Endotherapeutics for the device "ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE". The FDA issued a decision of Substantially Equivalent on March 17, 1986. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Endotherapeutics has at least 6 other 510(k) clearances on record.