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FDA 510(k)

BiZact Open Sealer/Divider

K-Number: K160539 · 2016-06-15

ApplicantCovidien
Decision Date2016-06-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BiZact Open Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-06-15 under 510(k) 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. The listed applicant is Covidien. The 510(k) number is K160539.

When did BiZact Open Sealer/Divider receive FDA 510(k) clearance?

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

Who is the listed applicant for BiZact Open Sealer/Divider?

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

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

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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