C2 CryoBalloon EndoGrip
K-Number: K193036 · 2019-11-22
Decision Date2019-11-22
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
C2 CryoBalloon EndoGrip is a medical device manufactured by Pentax Medical, A Division of Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K193036. 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 C2 CryoBalloon EndoGrip?
C2 CryoBalloon EndoGrip is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Pentax Medical, A Division of Pentax of America, Inc.. The 510(k) number is K193036.
When was C2 CryoBalloon EndoGrip approved by the FDA?
C2 CryoBalloon EndoGrip received FDA 510(k) clearance on 2019-11-22, under approval number K193036.
What company makes C2 CryoBalloon EndoGrip?
C2 CryoBalloon EndoGrip is manufactured by Pentax Medical, A Division of Pentax of America, Inc..
What is the FDA product code for C2 CryoBalloon EndoGrip?
The FDA product code for C2 CryoBalloon EndoGrip is OCX.
Other Devices by Pentax Medical, A Division of Pentax of America, Inc.
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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.