# K991139: Guglielmi Detachable (GDC)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific, Target
- Decided: Dec 22, 1999 after 261 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). 23 ancestors in all.
138 later devices descend from it; 4 cite it directly.
1 of 162 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.
- K914786: Target Therapeutics Coils, Target Therapeutics (1992) Summary page 1.
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc, Deknatel, Inc. (1994) Summary page 1.

## Most influential descendants
- K012145: Microplex Coil System (2001), 96 descendants of its own
- K042539: GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil (2004), 86 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

## Indications for use
Boston Scientific/Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific/Target's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K991139
Methodology: https://510kreport.com/methodology