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FDA 510(k)

DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE

K-Number: K030343 · 2003-05-02

ApplicantGyrus Ent LLC
Decision Date2003-05-02
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2003-05-02 under 510(k) number K030343. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE?

DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE is a medical device that received FDA 510(k) clearance on 2003-05-02. The listed applicant is Gyrus Ent LLC. The 510(k) number is K030343.

When did DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE receive FDA 510(k) clearance?

DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE received FDA 510(k) clearance on 2003-05-02, under 510(k) number K030343.

Who is the listed applicant for DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE?

The FDA product code for DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE is HAW.

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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.

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