# ODB: Endoscopic Contamination Prevention Sheath

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 1994: 1
- 2006: 1
- 2008: 1
- 2016: 1
- 2019: 1

## Most-cited predicates
- K080550: Megachannel Endoscopic Overtube, Model OT22 (2008), cited by 1
- K943697: Trocars,Cannulae,Sheaths,Obturators (1994), cited by 1
- K153698: LumenR Tissue Retractor System (2016), cited by 1

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