# FZP: Clip, Implantable

- Device class: 2; regulation: 21 CFR 878.4300; FDA's rule: 510(k) required
- FDA decisions: 178
- 510(k) review time 2021–2025: median 113 days (middle half 57–227)
- Recalls: 27 (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)
- 2016: 5
- 2017: 4
- 2018: 4
- 2019: 1
- 2020: 2
- 2022: 3
- 2023: 3
- 2024: 2
- 2025: 5
- 2026: 2

## Most-cited predicates
- K994160: Coalescent Surgical Sutured-Clip (2000), cited by 11
- K012317: Coalescent Surgical U-Clip (2001), cited by 10
- K971588: Evi Sutured-Clip Applier (1997), cited by 9
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories (2002), cited by 7
- K982313: Horizon Titanium Clips, Horizon Tantalum Clips (1998), cited by 6
- K024366: Coalescent Surgical U-Clip and Accessories (2003), cited by 6
- K031623: Modification to Coalescent Surgical U-Clip and Accessories (2003), cited by 5
- K970793: Implantable Clip (1997), cited by 5
- K830503: Ligaclip Titanium Ligating Clip (1983), cited by 5
- K030311: Hem-O-Lok XL Clip (2003), cited by 5

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