510(k) · Cleared
ClearedGuglielmi Detachable (GDC)
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 Dec 22, 1999 as substantially equivalent to K962503 (Target Therapeutics, 1996) and 3 other predicates after a 261-day review. Its family tree reaches back 4 generations to 1995. 1 of the 162 devices in its family, counting itself, has a Class I recall. 138 later devices descend from it.
- Decided
- Dec 22, 1999
- Review
- 261 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K951256 (1995). 23 ancestors in all, the oldest K860840 (1986). 138 later devices descend from it, 4 citing it directly. 1 of the 162 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 3 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 2 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 1 generation backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- This deviceK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · cites it directly · 96 of its ownK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 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 · 70 of its ownK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- Descendant · 3 generations on · 68 of its ownK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 4 generations on · 67 of its ownK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
Showing 5 of 138 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 138 · See all- K012145Microplex Coil SystemMicroVention, Inc. · 2001 · cites it directly96descendants
- K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp · 2004 · cites it directly86descendants
- K020434Microplex Coil System (MCS)MicroVention, Inc. · 2002 · 2 generations on70descendants
- K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 3 generations on68descendants
- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 4 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −3 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −2 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −1 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| 0 (this device) | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +1 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| +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 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| +3 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +4 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K962503 | Guglielmi Detachable CoilSummary page 1…Il Common Name Occlusion Coil Classification N. Artificial Embolization Device (21 CFR Section 882.5950) Predi Devi Number Description Predicate for Clearance Date K962503 Guglielmi Detachable Coil | All GLX devices which | 20 Sept. 1996 {Boston are the subject of this Scientific / premarket notifica… | 1996 |
| * | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Summary page 1…for Clearance Date K962503 Guglielmi Detachable Coil | All GLX devices which | 20 Sept. 1996 {Boston are the subject of this Scientific / premarket notification Target) ¥971395 Shalf Life, Various Class II | For shelf-life validation | 14 July 1897 (Boston and Class ITT Devices for | method and subsequent… | 1997 |
| * | K914786 | Target Therapeutics CoilsSummary page 1…r shelf-life validation | 14 July 1897 (Boston and Class ITT Devices for | method and subsequent Scientific / placement of shelf-life Target) information on device label K914786 Platinum Fibered For Dacron/Polyester | April 1992 (Boston Occlusion Coils fiber of Fibered GDC Scientific / Target) K930738 Surg… | 1992 |
| * | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcSummary page 1…elf-life Target) information on device label K914786 Platinum Fibered For Dacron/Polyester | April 1992 (Boston Occlusion Coils fiber of Fibered GDC Scientific / Target) K930738 Surgical Sutures Suture material for 26 July 1954 {Deknatel, Stretch Resistant GDC Division of Howmedica, Inc) 51 Marc! O(RB\… | 1994 |
What descends from it? (138)
See all 1384 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012145 | Microplex Coil System | 2001 | 96 |
| K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil | 2004 | 86 |
| K021494 | GDC Power Supply, Model GDC Power Supply: 451007-4 | 2002 | 60 |
| 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 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K012145 (MicroVention, Inc., 2001) has gone furthest, with 96 descendants of its own.
- 9 other devices also cite its predicate K962503.
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?
Boston Scientific/Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific/Target's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and 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/K991139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991139: Guglielmi Detachable (GDC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991139
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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