# K901337: Hilal Embolization Microcoil (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 13, 1990 after 236 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
139 later devices descend from it; 7 cite it directly.
1 of 140 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964367: Ces Vascular Occlusion System (1997), 80 descendants of its own
- K972881: Ces Vascular Occlusion System (1998), 79 descendants of its own
- K983483: Vascular Occlusion System (1999), 78 descendants of its own
- K993418: Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil (2000), 69 descendants of its own
- K033836: Hydrocoil Embolic System (Hes) (2003), 67 descendants of its own

## Recalls of this device
- May 8, 2008 · Not classified · Z-2058-2008: The product length is declared incorrectly in mm when the unit of measurement should be cm.
- May 8, 2008 · Not classified · Z-2057-2008: The product length is declared incorrectly in mm when the unit of measurement should be cm.

Source page: https://510kreport.com/device/K901337
Methodology: https://510kreport.com/methodology