510(k) · Cleared
Recalled · Class II · 2013GDC Stretch Resistant Detachable Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · HCG Device, Neurovascular Embolization
Cleared on Mar 14, 2003 as substantially equivalent to K001083 (Boston Scientific, Target, 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 1 of the 130 devices in its family, counting itself, has a Class I recall. 128 later devices descend from it. It has been recalled once.
- Decided
- Mar 14, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001083 (2000). 128 later devices descend from it, 2 citing it directly. 1 of the 130 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK001083 Guglielmi Detachable Coil and Power Supply, Models Power Supply…Boston Scientific, Target · 2000
- This deviceK030475 GDC Stretch Resistant Detachable CoilBoston Scientific, Target · 2003
- Descendant · cites it directly · 100 of its ownK031168 Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · Recalled
- Descendant · cites it directly · 86 of its ownK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- Descendant · 2 generations on · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- Descendant · 3 generations on · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 59 of its ownK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…6 generations on · 2022
Most influential descendants
Showing 5 of 128 · See all- K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · cites it directly100descendants
- K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp · 2004 · cites it directly86descendants
- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 2 generations on66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · 3 generations on65descendants
- K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · 2 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4… | Boston Scientific, Target | 2000 | — |
| 0 (this device) | K030475 | GDC Stretch Resistant Detachable Coil | Boston Scientific, Target | 2003 | — |
| +1 | K031168 | Matrix Stretch Resistant Detachable Coil | Boston Scientific, Target | 2003 | 10 |
| +1 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| +2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +3 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| +2 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 1 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables… | 2000 |
| 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 |
What descends from it? (128)
See all 1282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2013 | Class II | Z-0502-2014 | Software Manufacturing/Software Deployment | 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. |
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 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 neurovasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030475: GDC Stretch Resistant Detachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030475
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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