# K960705: Guglielmi Detachable Coil

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: May 21, 1996 after 90 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: 1 generation back to K951256 (1995). 1 ancestor in all.
190 later devices descend from it; 7 cite it directly.
1 of 192 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.
- (no number) Cook Occlusion Coils: named in the summary without a submission number

## Most influential descendants
- K962503: Guglielmi Detachable Coil (1996), 182 descendants of its own
- 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

## 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 arteriovencus ftistulae of the neuro vasculature.

Source page: https://510kreport.com/device/K960705
Methodology: https://510kreport.com/methodology