510(k) K071150

TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE by Heinz Kurz GmbH Medizintechnik — Product Code ETD

K071150 is an FDA 510(k) premarket notification submitted by Heinz Kurz GmbH Medizintechnik for the device "TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE". The FDA issued a decision of Substantially Equivalent on December 12, 2007. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Heinz Kurz GmbH Medizintechnik has at least 10 other 510(k) clearances on record.