# HCH: Clip, Aneurysm

- Device class: 2; regulation: 21 CFR 882.5200; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 316 days (middle half 316–316)
- 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)
- 2000: 2
- 2001: 4
- 2003: 3
- 2004: 1
- 2007: 1
- 2008: 1
- 2009: 2
- 2014: 1
- 2019: 1
- 2022: 1

## Most-cited predicates
- K955064: Spetzler TI 100 Aneurysm Clip (1996), cited by 6
- K983758: Yasargil Titanium Aneurysm Clips (1998), cited by 4
- K913765: Yasargil Aneurysm Clips, Modification (1992), cited by 3
- K970050: Yasargil Titanium Aneurysm Clips (Ftxxxt) (1997), cited by 3
- K922272: Yasargil Aneurysm Clips (1992), cited by 3
- K833652: Yasargil Fenestrated Aneurysm Clip & (1984), cited by 2
- K912456: Sundt Slim-Line Graft Clips (1995), cited by 2
- K003519: Yasargil Permanent Aneurysm Clips (2001), cited by 2
- K772200: Yasargil Aneurysm Clips (1977), cited by 2
- K131500: Yasargil Aneurysm Clips and Clip Appliers (2014), cited by 2

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