# ODA: Endoscopic Central Control Unit

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 67 days (middle half 61–112)
- 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)
- 2008: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2016: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K981993: Olympus Integrated Endosurgery System Endoalpha (1998), cited by 5
- K022270: Modification to Olympus Integrated Endosurgery System Endoalpha (2002), cited by 2
- K994231: Siemens Integrated Operating System (Sios) (2000), cited by 2
- K051613: Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 3 (2005), cited by 2
- K080410: Karl Storz SCB/Conmed Esu Interface Module, Model 20091522 (2008), cited by 1
- K192876: INTELLIO Tablet Application (2020), cited by 1
- K203566: Tablet Application (2021), cited by 1
- K111165: Karl Storz SCB / Covidien Forcetriad Interface Module (2012), cited by 1
- K041912: SCB/Valleylab Force FX Interface Unit (2004), cited by 1
- K070827: Karl Storz SCB Interface Control, Model 20090120 (2007), cited by 1

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