# K042539: GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 19, 2004 after 29 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
Longest line of descent: 5 generations back to K951256 (1995). 26 ancestors in all.
86 later devices descend from it; 4 cite it directly.
1 of 113 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991139: Guglielmi Detachable (GDC), Boston Scientific, Target (1999) Summary page 1.
- K001083: Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4, Boston Scientific, Target (2000) Summary page 1.
- K030475: GDC Stretch Resistant Detachable Coil, Boston Scientific, Target (2003) Summary page 1.

## Most influential descendants
- K050700: Matrix Stretch Resistant (SR) Coils (2005), 59 descendants of its own
- K093142: Target Detachable Coils and Inzone Detachment System (2010), 58 descendants of its own
- K063653: Micrus Microcoil System, Cashmere Model SRC (2007), 35 descendants of its own
- K070707: Micrus Microcoil System (2007), 32 descendants of its own
- K073442: Micrus Microcoil Systems (2008), 31 descendants of its own

## Recalls of this device
- Mar 21, 2016 · Class II · Z-1517-2016: The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
- Mar 21, 2016 · Class II · Z-1516-2016: The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.

## Indications for use
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patienVs general medical condition - are considered by the treating neurosurgical team to be: a) very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular nealformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K042539
Methodology: https://510kreport.com/methodology