510(k) · Cleared
Recalled · Class II · 2016GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · HCG Device, Neurovascular Embolization
Cleared on Oct 19, 2004 as substantially equivalent to K991139 (Boston Scientific, Target, 1999) and 2 other predicates after a 29-day review. Its family tree reaches back 5 generations to 1995. 1 of the 113 devices in its family, counting itself, has a Class I recall. 86 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 19, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K951256 (1995). 26 ancestors in all, the oldest K860840 (1986). 86 later devices descend from it, 4 citing it directly. 1 of the 113 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 4 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 2 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 1 generation backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- This deviceK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004
- Descendant · cites it directly · 59 of its ownK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- Descendant · cites it directly · 58 of its ownK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · cites it directly · 35 of its ownK063653 Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation · 2007
- Descendant · 2 generations on · 32 of its ownK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- Descendant · 3 generations on · 31 of its ownK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…5 generations on · 2022
Most influential descendants
Showing 5 of 86 · See all- K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · cites it directly59descendants
- K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010 · cites it directly58descendants
- K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation · 2007 · cites it directly35descendants
- K070707Micrus Microcoil SystemMicrus Endovascular Corporation · 2007 · 2 generations on32descendants
- K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −4 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −2 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −1 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| 0 (this device) | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | — |
| +1 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| +1 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +1 | K063653 | Micrus Microcoil System, Cashmere Model SRC | Micrus Endovascular Corporation | 2007 | — |
| +2 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| +3 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K991139 | Guglielmi Detachable (GDC)Summary page 1…ization Device (21 CFR Section 882.5950) Predicate Devices Number Description Predicate for Clearance Date K991139 Guglielmi Detachable coil design of: 22 Dec. 1999 (Boston Coil (GDC) System with… | 1999 |
| * | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables…Summary page 1…-10 3600 Coil SR Scientific / Version 4 Modifications GDC-10 3600 Soft Coil SR Target) GDC-18 3600 Coil K001083 Guglielmi Detachable coil design of: 3 May 2000 (Boston Coil, Additional GDC… | 2000 |
| * | K030475 | GDC Stretch Resistant Detachable CoilSummary page 1…-10 3600 Coil SR Scientific / Version 4 Modifications GDC-10 3600 Soft Coil SR Target) GDC-18 3600 Coil K030475 Guglielmi Detachable Anchor Chain component 14 March 2003 (Boston Coil, Modification of… | 2003 |
What descends from it? (86)
See all 864 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 |
|---|---|---|---|---|
| Mar 21, 2016 | Class II | Z-1517-2016 | Under Investigation by firm | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. |
| Mar 21, 2016 | Class II | Z-1516-2016 | Under Investigation by firm | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. |
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 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K050700 (Boston Scientific Corp, 2005) has gone furthest, with 59 descendants of its own.
- 3 other devices also cite its predicate K991139.
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 patienVs 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 nealformations 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/K042539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042539: GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042539
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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