510(k) · Cleared
Recalled · Class II · 2014GDC 360 Deteachable 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 Feb 16, 2011 as substantially equivalent to K031049 (Boston Scientific, Target, 2003) and 1 other predicate after a 92-day review. Its family tree reaches back 6 generations to 1995. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 16, 2011
- Review
- 92 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K951256 (1995). 28 ancestors in all, the oldest K860840 (1986). 16 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 2 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 1 generation backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- This deviceK103355 GDC 360 Deteachable CoilBoston Scientific Corp · 2011
- Descendant · cites it directly · 15 of its ownK123338 Barricade Embolization Coil SystemBlockade Medical · 2013
- Descendant · 2 generations on · 14 of its ownK131475 Barricade Embolization Coil SystemBlockade Medical · 2013
- Descendant · 2 generations on · 13 of its ownK132482 Barricade Embolization Coil SystemBlockade Medical · 2013
- Descendant · 2 generations on · 12 of its ownK140104 Barricade Embolization Coil SystemBlockade Medical · 2014
- Descendant · 2 generations on · 11 of its ownK142513 Barricade Embolization Coil SystemBlockade Medical · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123338Barricade Embolization Coil SystemBlockade Medical · 2013 · cites it directly15descendants
- K131475Barricade Embolization Coil SystemBlockade Medical · 2013 · 2 generations on14descendants
- K132482Barricade Embolization Coil SystemBlockade Medical · 2013 · 2 generations on13descendants
- K140104Barricade Embolization Coil SystemBlockade Medical · 2014 · 2 generations on12descendants
- K142513Barricade Embolization Coil SystemBlockade Medical · 2014 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −5 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −1 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| 0 (this device) | K103355 | GDC 360 Deteachable Coil | Boston Scientific Corp | 2011 | — |
| +1 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +2 | K131475 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +2 | K132482 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +2 | K140104 | Barricade Embolization Coil System | Blockade Medical | 2014 | — |
| +2 | K142513 | Barricade Embolization Coil System | Blockade Medical | 2014 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
Planning a device in HCG? 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 |
|---|---|---|---|
| * | K031049 | Guglielmi Detachable Coil (GDC)Summary page 7…ons for Use Summary of Clinical Data Boston Scientific Corporation previously submitted the 1-year results of the International Subarachnoid Aneurysm Trial (ISAT)' with K03 1049, which demonstrated a statistically significant reduction in the risk of dependency or death at 1 year post-treatment when patien… | 2003 |
| * | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilSummary page 6…of Non-Clinical Data A summary of the Non-clinical bench testing performed on the GDC® 3600 coils is provided in Table 1. These test results were previously provided in K042539, cleared 19 October 2004. Table 1: Verification Test Summary Predicate GDC® Device… | 2004 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123338 | Barricade Embolization Coil System | 2013 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2014 | Class II | Z-0478-2015 | Process control | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
| Oct 22, 2014 | Class II | Z-0479-2015 | Process control | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
| Oct 22, 2014 | Class II | Z-0480-2015 | Process control | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K123338 (Blockade Medical, 2013) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K031049.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
GDC® 360° Detachable Coils are intended for the endovascular embolization of-
* Intracranial aneurysms
* Other neurovascular abnormalities such as arteriovenous malformations and
arteriovenous fistulae
* Arterial and venous embolizations in the peripheral vasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103355: GDC 360 Deteachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103355
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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