# ODE: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 148 days (middle half 88–207)
- 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)
- 2001: 1
- 2003: 3
- 2007: 3
- 2009: 1
- 2012: 1
- 2014: 2
- 2015: 3
- 2016: 1
- 2017: 2
- 2024: 2

## Most-cited predicates
- K023234: Endoscopic Plication System (2003), cited by 6
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595 (2001), cited by 6
- K994290: Bard Endoscopic Suturing System (2000), cited by 4
- K071553: Endoscopic Plication System; Eps; Plicator (2007), cited by 4
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories (2007), cited by 3
- K032820: Modification to Endoscopic Plication System (2003), cited by 2
- K142113: ESOPHYX2 HD (2014), cited by 2
- K120299: SRS Endoscopic Stapling System (2012), cited by 1
- K132151: SRS Endoscopic Stapling System (2014), cited by 1
- K160960: EsophyX® Z Device with SerosaFuse Fasteners and Accessories (2016), cited by 1

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