Gdc-10 Stretch Resistant Guglielmi Detachable Coil, Gdc-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, Gdc-1

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K993415 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Matrix Detachable Coils

  Class II

  FDA 510(k) K012985 Active Cleared 31 Jan 2002

• Gdc Stretch Resistant Detachable Coil

  Class II

  FDA 510(k) K030475 Active Cleared 14 Mar 2003

• In-Time Retrieval Device

  Class II

  FDA 510(k) K014109 Active Cleared 12 Mar 2002

• Guglielmi Detachable Coil (Gdc)

  Class II

  FDA 510(k) K031049 Active Cleared 1 Aug 2003

• Gdc Ultrasoft Coil

  Class II

  FDA 510(k) K002181 Active Cleared 11 Aug 2000

• Gdc-10 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc), Gdc-18 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc)

  Class II

  FDA 510(k) K993417 Active Cleared 21 Jan 2000

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• What is the GDC-10 Stretch Resistant Guglielmi Detachable Coil used for?

  The GDC-10 Stretch Resistant Guglielmi Detachable Coil is designed for the occlusion of blood vessels in neurovascular procedures. It is specifically used to treat intracranial aneurysms and vascular malformations by promoting thrombosis within the target vessel lumen when deployed via endovascular techniques.

• How is the GDC-10 coil supplied and is it reusable?

  The device is supplied as a sterile, single-use implant intended for one patient and one procedure only. Reuse is not permitted due to risks of contamination, material degradation, and loss of detachability mechanism integrity, which could compromise patient safety and device performance.

• What components are part of the GDC system that includes the GDC-10 coil?

  The GDC system comprises the detachable coil, a power supply, delivery wire, connecting cables, and a patient return electrode. These components work together to enable precise placement and electrolytic detachment of the coil from the delivery wire during neurovascular embolization procedures.

• What regulatory pathway was used for the GDC-10 coil and when was it cleared?

  The GDC-10 Stretch Resistant Guglielmi Detachable Coil received FDA 510(k) clearance under submission K993415 on January 21, 2000. It was found substantially equivalent to predicate devices and is classified as a Class II medical device under regulation 882.5950 with product code HCG.