FDA 510(k)

UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)

K-Number: K964329 · 1997-05-21

ApplicantRichard Wolf Medical Instruments Corp.

Decision Date1997-05-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K964329. 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 UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)?

UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K964329.

When did UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) receive FDA 510(k) clearance?

UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) received FDA 510(k) clearance on 1997-05-21, under 510(k) number K964329.

Who is the listed applicant for UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)?

The FDA product code for UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) 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.