Decision Date2019-03-15
Product CodeKPI
Advisory CommitteeGU
DecisionUnknown
Device Summary
ApexMV is the device name listed in this FDA 510(k) record. The listed applicant is Incontrol Medical, LLC. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K182022. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Unknown.
Frequently Asked Questions
What is the ApexMV?
ApexMV is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Incontrol Medical, LLC. The 510(k) number is K182022.
When did ApexMV receive FDA 510(k) clearance?
ApexMV received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182022.
Who is the listed applicant for ApexMV?
The FDA 510(k) record lists Incontrol Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ApexMV?
The FDA product code for ApexMV is KPI.
Related Devices (Code: KPI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.