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FDA 510(k)

PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001

K-Number: K083013 · 2008-12-09

ApplicantGyrus Acmi, Inc.
Decision Date2008-12-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2008-12-09 under 510(k) number K083013. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001?

PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K083013.

When did PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 receive FDA 510(k) clearance?

PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 received FDA 510(k) clearance on 2008-12-09, under 510(k) number K083013.

Who is the listed applicant for PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001?

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

What is the FDA product code for PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001?

The FDA product code for PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 is GEI.

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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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