# Cogentix Medical, Inc.

- Location (FDA's records): Orangeburg, NY
- FDA decisions: 2 (2018–2026): 2 510(k) clearances
- Product codes: EOX (1), FAJ (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vision-Sciences, Inc.: 5 (https://510kreport.com/company/vision-sciences)

## Recent decisions
- K253905: PrimeSight UltraView System (Apr 7, 2026)
- K181292: PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (Nov 15, 2018)

Source page: https://510kreport.com/company/cogentix-medical