510(k) · Cleared
Recalled · Class II · 2013Fibered GDC-18 Vortx Shape Guglielmi 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 Jan 21, 2000 as substantially equivalent to K962503 (Target Therapeutics, 1996) and 4 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1995. 69 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2000
- Review
- 112 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 4 generations to K951256 (1995). 24 ancestors in all, the oldest K860840 (1986). 69 later devices descend from it, 2 citing it directly.
- 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 deviceK993418 Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target · 2000
- 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
- Descendant · 2 generations on · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- Descendant · 3 generations on · 35 of its ownK082461 Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · cites it directly67descendants
- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 2 generations on66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · 2 generations on65descendants
- K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · 2 generations on36descendants
- K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008 · 3 generations on35descendants
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) | K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil | Boston Scientific, Target | 2000 | — |
| +1 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +2 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| +2 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| +3 | K082461 | Bare Platinum Framing Coil, Model (S)… | MicroVention, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 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 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 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? (5)
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…n Name Occlusion Coil Classification Name Artificial Embolization Device (21 CFR Section 882.5950) Predicate Devices Number Description Predicate for Clearance Date K962503 Guglielmi Fibered GDC-18 VortX 20 Sept. 1996 (Boston Scientific / | Detachable Coil Shape Guglielmi Detachable Target) Coils K914… | 1996 |
| * | K914786 | Target Therapeutics CoilsSummary page 1…ription Predicate for Clearance Date K962503 Guglielmi Fibered GDC-18 VortX 20 Sept. 1996 (Boston Scientific / | Detachable Coil Shape Guglielmi Detachable Target) Coils K914786 Occlusion Coils Dacron, polyester fiber 20 April 1992 (Boston Scientific / material Target) K971395 Shelf Life, Various | For she… | 1992 |
| * | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Summary page 1…ientific / | Detachable Coil Shape Guglielmi Detachable Target) Coils K914786 Occlusion Coils Dacron, polyester fiber 20 April 1992 (Boston Scientific / material Target) K971395 Shelf Life, Various | For shelf-life validation 14 July 1997 (Boston Scientific / | Class Il and Class | method and subsequent Ta… | 1997 |
| * | K901337 | Hilal Embolization Microcoil (TM)Summary page 1…ife validation 14 July 1997 (Boston Scientific / | Class Il and Class | method and subsequent Target) III Devices for placement of shelf-life information on device label K901337 Tornado™ Graduated Helical Shape 13 Nov. 1990 and/or Embolization Coils K940982 14 Oct. 1994 (Cook, Inc.) 510(k) Notification Bos… | 1990 |
| * | K940982 | Arterial Embolization Device (KRD)Summary page 1…nd subsequent Target) III Devices for placement of shelf-life information on device label K901337 Tornado™ Graduated Helical Shape 13 Nov. 1990 and/or Embolization Coils K940982 14 Oct. 1994 (Cook, Inc.) 510(k) Notification Boston Scientific/Target Fibered GDC September 1999 CONFIDENTIAL Section 2, Page 2… | 1994 |
What descends from it? (69)
See all 692 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2013 | Class II | Z-0504-2014 | 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. |
No ancestor or descendant has a 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 24 ancestors have a recall of any class.
- Of its descendants, K033836 (MicroVention, Inc., 2003) has gone furthest, with 67 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 Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Fibered 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/K993418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993418: Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993418
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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