POWERSEAL Sealer and Divider
K-Number: K231327 · 2023-10-25
ApplicantGyrus Acmi, Inc.
Decision Date2023-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
POWERSEAL Sealer and Divider is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2023-10-25 under approval number K231327. 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 POWERSEAL Sealer and Divider?
POWERSEAL Sealer and Divider is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K231327.
When was POWERSEAL Sealer and Divider approved by the FDA?
POWERSEAL Sealer and Divider received FDA 510(k) clearance on 2023-10-25, under approval number K231327.
What company makes POWERSEAL Sealer and Divider?
POWERSEAL Sealer and Divider is manufactured by Gyrus Acmi, Inc..
What is the FDA product code for POWERSEAL Sealer and Divider?
The FDA product code for POWERSEAL Sealer and 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.