Cryo 7
K-Number: K220020 · 2022-02-04
ApplicantZimmer Medizinsysteme GmbH
Decision Date2022-02-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cryo 7 is a medical device manufactured by Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2022-02-04 under approval number K220020. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cryo 7?
Cryo 7 is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Zimmer Medizinsysteme GmbH. The 510(k) number is K220020.
When was Cryo 7 approved by the FDA?
Cryo 7 received FDA 510(k) clearance on 2022-02-04, under approval number K220020.
What company makes Cryo 7?
Cryo 7 is manufactured by Zimmer Medizinsysteme GmbH.
What is the FDA product code for Cryo 7?
The FDA product code for Cryo 7 is GEX. This falls under the Gastroenterology category.
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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.