FDA 510(k)

TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE

K-Number: K071150 · 2007-12-12

Decision Date2007-12-12

Product CodeETD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Heinz Kurz GmbH Medizintechnik. It received FDA 510(k) clearance on 2007-12-12 under 510(k) number K071150. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE?

TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE is a medical device that received FDA 510(k) clearance on 2007-12-12. The listed applicant is Heinz Kurz GmbH Medizintechnik. The 510(k) number is K071150.

When did TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE receive FDA 510(k) clearance?

TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE received FDA 510(k) clearance on 2007-12-12, under 510(k) number K071150.

Who is the listed applicant for TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE?

The FDA 510(k) record lists Heinz Kurz GmbH Medizintechnik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE?

The FDA product code for TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE is ETD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.