FDA 510(k)

FISCH TITANIUM MIDDLE EAR PROSTHESES

K-Number: K043375 · 2005-01-24

Decision Date2005-01-24

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

FISCH TITANIUM MIDDLE EAR PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 2005-01-24 under 510(k) number K043375. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISCH TITANIUM MIDDLE EAR PROSTHESES?

FISCH TITANIUM MIDDLE EAR PROSTHESES is a medical device that received FDA 510(k) clearance on 2005-01-24. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K043375.

When did FISCH TITANIUM MIDDLE EAR PROSTHESES receive FDA 510(k) clearance?

FISCH TITANIUM MIDDLE EAR PROSTHESES received FDA 510(k) clearance on 2005-01-24, under 510(k) number K043375.

Who is the listed applicant for FISCH TITANIUM MIDDLE EAR PROSTHESES?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FISCH TITANIUM MIDDLE EAR PROSTHESES?

The FDA product code for FISCH TITANIUM MIDDLE EAR PROSTHESES is ETA.

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Official Source

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