510(k) Report

510(k) · Cleared

Cleared

Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4

K001083510(k) SpecialCleared May 3, 200029-day reviewClass II21 CFR 882.5950

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific, Target · HCG Device, Neurovascular Embolization

Cleared on May 3, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 144 devices in its family, counting itself, has a Class I recall. 143 later devices descend from it.

Decided
May 3, 2000
Review
29 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
0

143 later devices descend from it, 7 citing it directly. 1 of the 144 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 5 descendants cleared2003: 5 descendants cleared2013: 11 descendants cleared2004: 2 descendants cleared2005: 5 descendants cleared2010: 7 descendants cleared2009: 9 descendants cleared2011: 9 descendants cleared2007: 5 descendants cleared2014: 7 descendants cleared2015: 8 descendants cleared2006: 1 descendant cleared2012: 10 descendants cleared2022: 7 descendants cleared, 1 with a Class I recall12018: 5 descendants cleared2020: 3 descendants cleared2008: 6 descendants cleared2017: 6 descendants cleared2016: 7 descendants cleared2019: 2 descendants cleared2021: 6 descendants cleared2025: 5 descendants cleared2023: 2 descendants cleared2024: 4 descendants cleared2026: 6 descendants cleared200020052010201520202025
  1. This deviceK001083 Guglielmi Detachable Coil and Power Supply, Models Power Supply…Boston Scientific, Target · 2000
  2. Descendant · cites it directly · 128 of its ownK030475 GDC Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · Recalled
  3. Descendant · cites it directly · 122 of its ownK012985 Matrix Detachable CoilsBoston Scientific, Target · 2002 · Recalled
  4. Descendant · 2 generations on · 100 of its ownK031168 Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · Recalled
  5. 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
  6. Descendant · 2 generations on · 70 of its ownK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2002: 52003: 52004: 22005: 52006: 12007: 52008: 62009: 92010: 72011: 92012: 102013: 112014: 72015: 82016: 72017: 62018: 52019: 22020: 32021: 62022: 72023: 22024: 42025: 52026: 6
2002high 11 (2013) · low 1 (2006)2026

Class I recalls in this family

  • K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…6 generations on · 2022

Most influential descendants

Showing 5 of 143 · See all
  • K030475GDC Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · cites it directly128descendants
  • K012985Matrix Detachable CoilsBoston Scientific, Target · 2002 · cites it directly122descendants
  • K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · 2 generations on100descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001083Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4…Boston Scientific, Target2000—
+1K030475GDC Stretch Resistant Detachable CoilBoston Scientific, Target20031
+1K012985Matrix Detachable CoilsBoston Scientific, Target200210
+2K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target200310
+1K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree…Boston Scientific Corp20042
+2K020434Microplex Coil System (MCS)MicroVention, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200250
200350
200420
200550
200610
200750
200860
200990
201070
201190
2012100
2013110
201470
201580
201670
201760
201850
201920
202030
202160
202271
202320
202440
202550
202660
FIG. 1 — Lineage of K001083, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (143)

See all 143

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030475GDC Stretch Resistant Detachable CoilBoston Scientific, Target2003128
K012985Matrix Detachable CoilsBoston Scientific, Target2002122
K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp200486
K031049Guglielmi Detachable Coil (GDC)Boston Scientific, Target200360
K021494GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target200260
K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310
K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020

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?

  • Of its descendants, K030475 (Boston Scientific, Target, 2003) has gone furthest, with 128 descendants of its own.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCG

3in 2025

2007: 82008: 92009: 72010: 82011: 92012: 72013: 72014: 52015: 52016: 72017: 52018: 42019: 12020: 22021: 52022: 32023: 22024: 42025: 32026 (partial year): 4
2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007: 50 days median2008: 71 days median2009: 48 days median2010: 72 days median2011: 78 days median2012: 30 days median2013: 67 days median2014: 66 days median2015: 60 days median2016: 37 days median2017: 97 days median2018: 173 days median2021: 103 days median2022: 114 days median2024: 49 days median2025: 107 days median2026 (partial year): 30 days median
2007high 173 (2018) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HCG

1in 2025

2007: 12008: 32010: 22011: 12013: 22014: 42022: 22024: 12025: 1, 1 Class I2026 (partial year): 1
2007high 4 (2014) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HCG

537in 2025

2007: 3262008: 7302009: 8212010: 8512011: 8942012: 1,1462013: 1,1032014: 1,7292015: 1,5982016: 1,9912017: 2,4942018: 2,0582019: 1,7632020: 1,7542021: 2,2682022: 6632023: 5682024: 5522025: 537
2007high 2,494 (2017) · low 326 (2007)2025

MAUDE reports naming product code HCG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078501326
20089713730
20097480821
20108722851
20119781894
201273001,146
201376721,103
201456641,729
201556001,598
201673701,991
201759702,494
2018417302,058
20191—01,763
20202—01,754
2021510302,268
202231142663
20232—0568
20244491552
202531071 (1)537
20264301—

More from Boston Scientific, Target

19 FDA decisions under this applicant name. See the company

  • K031049Guglielmi Detachable Coil (GDC)Boston Scientific, Target · 2003
  • K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 200310 recalls
  • K030475GDC Stretch Resistant Detachable CoilBoston Scientific, Target · 20031 recall
  • K022860Atlantis PV Imaging Catheter, Model 36456Boston Scientific, Target · 2002
  • K022357Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815Boston Scientific, Target · 2002

Recent decisions in HCG

The HCG category page

  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • K261772Target Xtra Detachable CoilStryker Neurovscular · 2026
  • K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
  • K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
  • K252694Target Detachable CoilStryker Neurovascular · 2025

https://510kreport.com/device/K001083 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001083: Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001083

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026