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FDA 510(k)

FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE

K-Number: K073616 · 2008-07-23

ApplicantElectromedics Co. , Ltd.
Decision Date2008-07-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics Co. , Ltd.. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K073616. 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 FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE?

FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Electromedics Co. , Ltd.. The 510(k) number is K073616.

When did FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE receive FDA 510(k) clearance?

FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE received FDA 510(k) clearance on 2008-07-23, under 510(k) number K073616.

Who is the listed applicant for FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE?

The FDA 510(k) record lists Electromedics Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE?

The FDA product code for FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE 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.

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