troCarWash System
K-Number: K222695 · 2023-02-17
ApplicantBiotex, Inc.
Decision Date2023-02-17
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
troCarWash System is a medical device manufactured by Biotex, Inc.. It received FDA 510(k) clearance on 2023-02-17 under approval number K222695. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the troCarWash System?
troCarWash System is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Biotex, Inc.. The 510(k) number is K222695.
When was troCarWash System approved by the FDA?
troCarWash System received FDA 510(k) clearance on 2023-02-17, under approval number K222695.
What company makes troCarWash System?
troCarWash System is manufactured by Biotex, Inc..
What is the FDA product code for troCarWash System?
The FDA product code for troCarWash System is OCX.
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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.