# K962503: Guglielmi Detachable Coil

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Sep 20, 1996 after 85 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: 2 generations back to K951256 (1995). 2 ancestors in all.
182 later devices descend from it; 10 cite it directly.
1 of 185 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC), Target Therapeutics (1995) Summary page 2.
- K960705: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 2.

## Most influential descendants
- K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce (1997), 150 descendants of its own
- K991139: Guglielmi Detachable (GDC) (1999), 138 descendants of its own
- K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1 (2000), 105 descendants of its own
- K022420: Micrus Stretch-Resistant Microcoil System, MSR01 (2002), 103 descendants of its own
- K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC) (2000), 98 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 neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K962503
Methodology: https://510kreport.com/methodology