# PLL: Submucosal Injection Agent

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 90 days (middle half 60–134)
- Recalls: 1 (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)
- 2015: 1
- 2018: 1
- 2020: 4
- 2022: 2
- 2024: 1
- 2026: 1

## Most-cited predicates
- K150852: SIC 8000 (2015), cited by 5
- K191923: EverLift Submucosal Lifting Agent (2020), cited by 1
- K191254: EndoClot (2020), cited by 1
- K180068: ORISE Gel (2018), cited by 1
- K220434: Blue Eye (TS-905) (2022), cited by 1

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