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FDA 510(k)

HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor

K-Number: K200146 · 2020-05-07

ApplicantCovidien, LLC
Decision Date2020-05-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K200146. 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 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor?

HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Covidien, LLC. The 510(k) number is K200146.

When did HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor receive FDA 510(k) clearance?

HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200146.

Who is the listed applicant for HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor?

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

What is the FDA product code for HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor?

The FDA product code for HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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