# K031578: Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR

- Pathway: 510(k) (Traditional)
- Applicant: Micrus Corp.
- Decided: Aug 1, 2003 after 73 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951256 (1995). 25 ancestors in all.
91 later devices descend from it; 4 cite it directly.
1 of 117 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022420: Micrus Stretch-Resistant Microcoil System, MSR01, Micrus Corp. (2002) Summary page 5.

## Cited in the summary but kept off the family tree
- K0002056: Micrus Microcoil Delivery System. Number could not be read

## Most influential descendants
- K032590: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) (2003), 68 descendants of its own
- K033836: Hydrocoil Embolic System (Hes) (2003), 67 descendants of its own
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- K070656: Hydrocoil Embolic System (Hes) (2007), 36 descendants of its own

## Indications for use
Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K031578
Methodology: https://510kreport.com/methodology