# K030475: GDC Stretch Resistant Detachable Coil

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific, Target
- Decided: Mar 14, 2003 after 29 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001083 (2000). 1 ancestor in all.
128 later devices descend from it; 2 cite it directly.
1 of 130 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001083: Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4, Boston Scientific, Target (2000)

## Cited in the summary but kept off the family tree
- K020181: GDC 10-Ultrasoft Coil. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K031168: Matrix Stretch Resistant Detachable Coil (2003), 100 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
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- K050700: Matrix Stretch Resistant (SR) Coils (2005), 59 descendants of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0502-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

## 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/K030475
Methodology: https://510kreport.com/methodology