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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 a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2020-05-07 under approval 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. It is manufactured by Covidien, LLC. The 510(k) number is K200146.

When was HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor approved by the FDA?

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

What company makes HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor?

HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor is manufactured by Covidien, LLC.

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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