# K120686: Orbit Galaxy G2 Microcoil Delivery System

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Apr 4, 2012 after 29 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: 8 generations back to K951256 (1995). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072173: Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRC, Micrus Endovascular Corporation (2007) Summary page 1.
- K093973: Trufill DCS Orbit Detachable Coil System, Codman & Shurtleff, Inc. (2010) Summary page 1.

## Most influential descendants
- K142429: CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable (2014), 0 descendants of its own

## Indications for use
The Fill Orbit Galaxy® G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is intended for arterial and venous embolizations in the peripheral vasculature. The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K120686
Methodology: https://510kreport.com/methodology