Decision Date2022-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Alexis Contained Extraction System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K211043. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alexis Contained Extraction System?
Alexis Contained Extraction System is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K211043.
When did Alexis Contained Extraction System receive FDA 510(k) clearance?
Alexis Contained Extraction System received FDA 510(k) clearance on 2022-03-31, under 510(k) number K211043.
Who is the listed applicant for Alexis Contained Extraction System?
The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alexis Contained Extraction System?
The FDA product code for Alexis Contained Extraction System is GCJ.
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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.