Cryotop®US-flash and Cryotop®US-scoop
K-Number: K181469 · 2018-11-09
ApplicantKitazato Corporation
Decision Date2018-11-09
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Cryotop®US-flash and Cryotop®US-scoop is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2018-11-09 under approval number K181469. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cryotop®US-flash and Cryotop®US-scoop?
Cryotop®US-flash and Cryotop®US-scoop is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by Kitazato Corporation. The 510(k) number is K181469.
When was Cryotop®US-flash and Cryotop®US-scoop approved by the FDA?
Cryotop®US-flash and Cryotop®US-scoop received FDA 510(k) clearance on 2018-11-09, under approval number K181469.
What company makes Cryotop®US-flash and Cryotop®US-scoop?
Cryotop®US-flash and Cryotop®US-scoop is manufactured by Kitazato Corporation.
What is the FDA product code for Cryotop®US-flash and Cryotop®US-scoop?
The FDA product code for Cryotop®US-flash and Cryotop®US-scoop is MQK.
Other Devices by Kitazato Corporation
Related Devices (Code: MQK)
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.