FDA 510(k)

EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK

K-Number: K031082 · 2003-05-21

Decision Date2003-05-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical, Inc.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K031082. 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 EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK?

EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Gyrus Medical, Inc.. The 510(k) number is K031082.

When did EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK receive FDA 510(k) clearance?

EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK received FDA 510(k) clearance on 2003-05-21, under 510(k) number K031082.

Who is the listed applicant for EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK?

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

What is the FDA product code for EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK?

The FDA product code for EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK is GEI.

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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.