510(k) · Cleared
ClearedGuglielmi Detachable Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · HCG Device, Neurovascular Embolization
Cleared on Sep 20, 1996 as substantially equivalent to K951256 (Target Therapeutics, 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 1995. 1 of the 185 devices in its family, counting itself, has a Class I recall. 182 later devices descend from it.
- Decided
- Sep 20, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951256 (1995). 182 later devices descend from it, 10 citing it directly. 1 of the 185 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 1 generation backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- This deviceK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- Descendant · cites it directly · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- Descendant · cites it directly · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · cites it directly · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · 2 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- Descendant · cites it directly · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…4 generations on · 2022
Most influential descendants
Showing 5 of 182 · See all- K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · cites it directly150descendants
- K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · cites it directly138descendants
- K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · cites it directly105descendants
- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 2 generations on103descendants
- K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · cites it directly98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −1 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| 0 (this device) | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| +1 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| +1 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +1 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +2 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| +1 | K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi… | Boston Scientific, Target | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 12 | 0 |
| 2010 | 8 | 0 |
| 2011 | 12 | 0 |
| 2012 | 13 | 0 |
| 2013 | 12 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 1 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Summary page 2…ently cleared for use in intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature (K951256, K960705). The purpose of this submission is to expand the indications to include peripheral indications. Indications for Use C… | 1995 |
| * | K960705 | Guglielmi Detachable CoilSummary page 2…red for use in intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature (K951256, K960705). The purpose of this submission is to expand the indications to include peripheral indications. Indications for Use Comparison… | 1996 |
What descends from it? (182)
See all 18210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid… | 1997 | 150 |
| K991139 | Guglielmi Detachable (GDC) | 1999 | 138 |
| K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant… | 2000 | 105 |
| K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil… | 2000 | 98 |
| K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil | 2000 | 69 |
| K993455 | Flipper Detachable Embolization Coil | 2000 | 41 |
| K031810 | Amplatzer Vascular Plug | 2003 | 38 |
| K073442 | Micrus Microcoil Systems | 2008 | 31 |
| K081465 | Axium Detachable Coil System | 2008 | 22 |
| K014041 | Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS… | 2002 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K971395 (Target Therapeutics, 1997) has gone furthest, with 150 descendants of its own.
- 7 other devices also cite its predicate K951256.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962503: Guglielmi Detachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962503
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026