# OCS: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1

## Most-cited predicates
- K100852: Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 (2010), cited by 1

Source page: https://510kreport.com/product-code/OCS
Data by year (CSV): https://510kreport.com/product-code/OCS.csv