510(k) · Cleared
ClearedGDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1
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 Jan 21, 2000 as substantially equivalent to K962503 (Target Therapeutics, 1996) and 2 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1995. 1 of the 129 devices in its family, counting itself, has a Class I recall. 105 later devices descend from it.
- Decided
- Jan 21, 2000
- Review
- 112 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951256 (1995). 23 ancestors in all, the oldest K860840 (1986). 105 later devices descend from it, 3 citing it directly. 1 of the 129 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 deviceK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · cites it directly · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- Descendant · 2 generations on · 91 of its ownK031578 Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp. · 2003
- Descendant · 3 generations on · 68 of its ownK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · cites it directly · 67 of its ownK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 2 generations on · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
Showing 5 of 105 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 105 · See all- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · cites it directly103descendants
- K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp. · 2003 · 2 generations on91descendants
- K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 3 generations on68descendants
- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · cites it directly67descendants
- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 2 generations on66descendants
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) | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +1 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| +2 | K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR | Micrus Corp. | 2003 | — |
| +3 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +1 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
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 |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K962503 | Guglielmi Detachable CoilSummary page 2…GDC-18 Stretch Resistant GDC September 1999 CONFIDENTIAL Section 2, Page 2 KAz 41s~ Predicate Devices Number Description Predicate for Clearance Date K962503 Guglielmi Detachable Coil | GDC-10 and GDC-10 | 20 Sept. 1996 (Boston Scientific / (2D) Stretch Resistant Target) Guglielmi Deta… | 1996 |
| * | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcSummary page 2…0 Sept. 1996 (Boston Scientific / (2D) Stretch Resistant Target) Guglielmi Detachable Coils and GDC-18 and GDC-18 (2D) Stretch Resistant Guglielmi Detachable Coils K930738 (Deknatel, | Implantable Surgical Suture material 26 July 1994 Division of Sutures Howmedica, Inc.) K971395 Shelf Life, Various C… | 1994 |
| * | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Summary page 2…d GDC-18 (2D) Stretch Resistant Guglielmi Detachable Coils K930738 (Deknatel, | Implantable Surgical Suture material 26 July 1994 Division of Sutures Howmedica, Inc.) K971395 Shelf Life, Various Class I | For shelf-life 14 July 1997 (Boston Scientific / | and Class III Devices for validation method Targ… | 1997 |
What descends from it? (105)
See all 1053 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)
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 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 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, K022420 (Micrus Corp., 2002) has gone furthest, with 103 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993415
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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