Decision Date2025-10-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Kii Structural Balloon Access System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252442. 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 Kii Structural Balloon Access System?
Kii Structural Balloon Access System is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K252442.
When did Kii Structural Balloon Access System receive FDA 510(k) clearance?
Kii Structural Balloon Access System received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252442.
Who is the listed applicant for Kii Structural Balloon Access System?
The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kii Structural Balloon Access System?
The FDA product code for Kii Structural Balloon Access 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.