# ODD: Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- 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)
- 1989: 1
- 1991: 1
- 1995: 2
- 1996: 1
- 1997: 2
- 2001: 2
- 2007: 1
- 2018: 1
- 2020: 1
- 2025: 1

## Most-cited predicates
- K070420: Bioshield-Ercp Biopsy Valve, Model 00711138 (2007), cited by 4
- K011149: Disposable Bending Cannula PR-233Q (2001), cited by 2
- K833417: Endoscopic Retrograde (1983), cited by 1
- K202583: BioShield biopsy valve EUS - Linear (2020), cited by 1
- K950729: Olympus PR-23Q Disposable Cannula (Ball Tip) (1995), cited by 1
- K171989: Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter (2018), cited by 1

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