Decision Date2023-11-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Inzii Ripstop Redeployable Retrieval 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 2023-11-01 under 510(k) number K232880. 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 Inzii Ripstop Redeployable Retrieval System?
Inzii Ripstop Redeployable Retrieval System is a medical device that received FDA 510(k) clearance on 2023-11-01. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K232880.
When did Inzii Ripstop Redeployable Retrieval System receive FDA 510(k) clearance?
Inzii Ripstop Redeployable Retrieval System received FDA 510(k) clearance on 2023-11-01, under 510(k) number K232880.
Who is the listed applicant for Inzii Ripstop Redeployable Retrieval 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 Inzii Ripstop Redeployable Retrieval System?
The FDA product code for Inzii Ripstop Redeployable Retrieval 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.