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FDA 510(k)

ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200

K-Number: K100258 · 2010-04-28

ApplicantWickimed Supply Limited
Decision Date2010-04-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed Supply Limited. It received FDA 510(k) clearance on 2010-04-28 under 510(k) number K100258. 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 ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200?

ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 is a medical device that received FDA 510(k) clearance on 2010-04-28. The listed applicant is Wickimed Supply Limited. The 510(k) number is K100258.

When did ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 receive FDA 510(k) clearance?

ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 received FDA 510(k) clearance on 2010-04-28, under 510(k) number K100258.

Who is the listed applicant for ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200?

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

What is the FDA product code for ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200?

The FDA product code for ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 is GEI.

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Official Source

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