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FDA 510(k)

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

K-Number: K171066 · 2017-06-08

ApplicantCovidien, LLC
Decision Date2017-06-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2017-06-08 under approval number K171066. 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 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Covidien, LLC. The 510(k) number is K171066.

When was BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider approved by the FDA?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider received FDA 510(k) clearance on 2017-06-08, under approval number K171066.

What company makes BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is manufactured by Covidien, LLC.

What is the FDA product code for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

The FDA product code for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider 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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