# K160219: Hilal Embolization MicroCoils

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 3, 2016 after 187 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951256 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123712: Retracta Detachable Embolization Coil, Cook Incorporated (2013) Summary page 4.
- K151676: Retracta Detachable Embolization Coil, Cook Incorporated (2015) Summary page 4.

## Recalls of this device
- May 5, 2022 · Class II · Z-1240-2022: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

## Indications for use
The Hilal Embolization MicroCoils™ are intended for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K160219
Methodology: https://510kreport.com/methodology