# PCU: Pancreatic Stent, Covered, Metallic, Removable

- Device class: 2; regulation: 21 CFR 876.5015; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 208 days (middle half 193–222)
- Recalls: 6 (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)
- 2013: 1
- 2014: 1
- 2015: 3
- 2017: 1
- 2019: 2
- 2021: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K181905: AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (2019), cited by 3
- DEN130007: Axios Stent and Delivery System (2013), cited by 2
- K153088: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (2015), cited by 2
- K150692: AXIOS Stent with Electrocautery Enhanced Delivery System (2015), cited by 2
- K140561: Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent) (2014), cited by 2
- K192043: AXIOS Stent and Electrocautery Enhanced Delivery System (2019), cited by 1
- K220112: AXIOS Stent and Electrocautery-Enhanced Delivery System (2022), cited by 1
- K163272: AXIOS Stent and Electrocautery Enhanced Delivery System (2017), cited by 1
- K152572: AXIOS Stent and Delivery System (2015), cited by 1
- K203132: AXIOS Stent and Electrocautery Enhanced Delivery System (2021), cited by 1

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