Flexset System
K-Number: K233403 · 2024-04-30
ApplicantZeto, Inc.
Decision Date2024-04-30
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Flexset System is a medical device manufactured by Zeto, Inc.. It received FDA 510(k) clearance on 2024-04-30 under approval number K233403. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Flexset System?
Flexset System is a medical device that received FDA 510(k) clearance on 2024-04-30. It is manufactured by Zeto, Inc.. The 510(k) number is K233403.
When was Flexset System approved by the FDA?
Flexset System received FDA 510(k) clearance on 2024-04-30, under approval number K233403.
What company makes Flexset System?
Flexset System is manufactured by Zeto, Inc..
What is the FDA product code for Flexset System?
The FDA product code for Flexset System is GWQ.
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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.