FDA 510(k)

ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP

K-Number: K053282 · 2005-12-13

Decision Date2005-12-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K053282. 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 ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP?

ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Pajunk GmbH. The 510(k) number is K053282.

When did ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP receive FDA 510(k) clearance?

ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP received FDA 510(k) clearance on 2005-12-13, under 510(k) number K053282.

Who is the listed applicant for ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP?

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

What is the FDA product code for ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP?

The FDA product code for ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP 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.