Decision Date2026-04-07
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PrimeSight UltraView System is the device name listed in this FDA 510(k) record. The listed applicant is Cogentix Medical, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) 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. The listed applicant is Cogentix Medical, Inc.. The 510(k) number is K253905.
When did PrimeSight UltraView System receive FDA 510(k) clearance?
PrimeSight UltraView System received FDA 510(k) clearance on 2026-04-07, under 510(k) number K253905.
Who is the listed applicant for PrimeSight UltraView System?
The FDA 510(k) record lists Cogentix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PrimeSight UltraView System?
The FDA product code for PrimeSight UltraView System is FAJ.
Other records listing Cogentix Medical, Inc. as applicant
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.
Related Devices (Code: FAJ)
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
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