# K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific, Target
- Decided: Jan 21, 2000 after 112 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: 4 generations back to K951256 (1995). 22 ancestors in all.
98 later devices descend from it; 3 cite it directly.
1 of 121 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962503: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 1.
- K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce, Target Therapeutics (1997) Summary page 1.

## Most influential descendants
- K012145: Microplex Coil System (2001), 96 descendants of its own
- K020434: Microplex Coil System (MCS) (2002), 70 descendants of its own
- 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

## Indications for use
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient’s 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 malformations 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/K993417
Methodology: https://510kreport.com/methodology