PrimeSight UltraView System
K-Number: K253905 · 2026-04-07
ApplicantCogentix Medical, Inc.
Decision Date2026-04-07
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PrimeSight UltraView System is a medical device manufactured by Cogentix Medical, Inc.. It received FDA 510(k) clearance on 2026-04-07 under approval number K253905. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PrimeSight UltraView System?
PrimeSight UltraView System is a medical device that received FDA 510(k) clearance on 2026-04-07. It is manufactured by Cogentix Medical, Inc.. The 510(k) number is K253905.
When was PrimeSight UltraView System approved by the FDA?
PrimeSight UltraView System received FDA 510(k) clearance on 2026-04-07, under approval number K253905.
What company makes PrimeSight UltraView System?
PrimeSight UltraView System is manufactured by Cogentix Medical, Inc..
What is the FDA product code for PrimeSight UltraView System?
The FDA product code for PrimeSight UltraView System is FAJ.
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Official Source
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