PIEZOTOME CUBE
K-Number: K172137 · 2018-05-03
ApplicantSatelec - Acteon Group
Decision Date2018-05-03
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PIEZOTOME CUBE is a medical device manufactured by Satelec - Acteon Group. It received FDA 510(k) clearance on 2018-05-03 under approval number K172137. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PIEZOTOME CUBE?
PIEZOTOME CUBE is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Satelec - Acteon Group. The 510(k) number is K172137.
When was PIEZOTOME CUBE approved by the FDA?
PIEZOTOME CUBE received FDA 510(k) clearance on 2018-05-03, under approval number K172137.
What company makes PIEZOTOME CUBE?
PIEZOTOME CUBE is manufactured by Satelec - Acteon Group.
What is the FDA product code for PIEZOTOME CUBE?
The FDA product code for PIEZOTOME CUBE is DZI.
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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.