FDA 510(k)

BiZact Open Sealer/Divider

K-Number: K160539 · 2016-06-15

Decision Date2016-06-15

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BiZact Open Sealer/Divider is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-06-15 under approval number K160539. 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 Open Sealer/Divider?

BiZact Open Sealer/Divider is a medical device that received FDA 510(k) clearance on 2016-06-15. It is manufactured by Covidien. The 510(k) number is K160539.

When was BiZact Open Sealer/Divider approved by the FDA?

BiZact Open Sealer/Divider received FDA 510(k) clearance on 2016-06-15, under approval number K160539.

What company makes BiZact Open Sealer/Divider?

BiZact Open Sealer/Divider is manufactured by Covidien.

What is the FDA product code for BiZact Open Sealer/Divider?

The FDA product code for BiZact Open Sealer/Divider 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.