# HCI: Applier, Aneurysm Clip

- Device class: 2; regulation: 21 CFR 882.4175; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 118 days (middle half 73–162)
- Recalls: 2 (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)
- 1995: 1
- 1996: 1
- 1998: 1
- 1999: 1
- 2000: 1
- 2001: 1
- 2017: 1
- 2018: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K940970: Yasargil, Caspar, Vario Clip Appliers (1995), cited by 4
- K833651: Clip Applying Forceps (1983), cited by 3
- K984109: Aesculap Axial Clip Applier (1999), cited by 3
- K902544: Sundt Avm Micro Clip (1990), cited by 2
- K211572: Aesculap Slim Clip Applier (2021), cited by 1
- K881911: New Sizes Sugita Clips (1988), cited by 1
- K982379: Sundt Slim-Line Aneurysm Clip Applier (1998), cited by 1
- K180914: Aesculap Slim Clip Applier (2018), cited by 1
- K173271: Aesculap Slim Clip Applier Forceps (2017), cited by 1

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