Gamma4 System
K-Number: K222309 · 2022-11-15
ApplicantStryker GmbH
Decision Date2022-11-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Gamma4 System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2022-11-15 under approval number K222309. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gamma4 System?
Gamma4 System is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Stryker GmbH. The 510(k) number is K222309.
When was Gamma4 System approved by the FDA?
Gamma4 System received FDA 510(k) clearance on 2022-11-15, under approval number K222309.
What company makes Gamma4 System?
Gamma4 System is manufactured by Stryker GmbH.
What is the FDA product code for Gamma4 System?
The FDA product code for Gamma4 System is HSB.
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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.