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FDA 510(k)

Alexis Contained Extraction System

K-Number: K211043 · 2022-03-31

ApplicantApplied Medical Resources Corporation
Decision Date2022-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Alexis Contained Extraction System is a medical device manufactured by Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-03-31 under approval 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. It is manufactured by Applied Medical Resources Corporation. The 510(k) number is K211043.

When was Alexis Contained Extraction System approved by the FDA?

Alexis Contained Extraction System received FDA 510(k) clearance on 2022-03-31, under approval number K211043.

What company makes Alexis Contained Extraction System?

Alexis Contained Extraction System is manufactured by Applied Medical Resources Corporation.

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.

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