Cogentix Medical, Inc.

FDA Regulatory Profile

Cogentix Medical, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 7, 2026.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
7
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253905PrimeSight UltraView SystemApril 7, 2026
K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorNovember 15, 2018