# HCG: Device, Neurovascular Embolization

- Device class: 2; regulation: 21 CFR 882.5950; FDA's rule: 510(k) required
- FDA decisions: 187
- 510(k) review time 2021–2025: median 103 days (middle half 29–123)
- Recalls: 18 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 4
- 2019: 1
- 2020: 2
- 2021: 5
- 2022: 3
- 2023: 2
- 2024: 4
- 2025: 3
- 2026: 4

## Most-cited predicates
- K962503: Guglielmi Detachable Coil (1996), cited by 10
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), cited by 9
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) (1995), cited by 8
- K991549: Embosphere Microspheres (2000), cited by 7
- K001083: Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4 (2000), cited by 7
- K901337: Hilal Embolization Microcoil (TM) (1990), cited by 7
- K002056: Micrus Microcoil Delivery System, MDS03 (2001), cited by 7
- K944354: Contour Emboli (1994), cited by 7
- K093142: Target Detachable Coils and Inzone Detachment System (2010), cited by 7
- K960705: Guglielmi Detachable Coil (1996), cited by 7

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