510(k) · Cleared

Cleared

Guglielmi Detachable Coil (GDC)

K031049510(k) TraditionalCleared Aug 1, 2003121-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 Aug 1, 2003 as substantially equivalent to K001083 (Boston Scientific, Target, 2000) after a 121-day review. Its family tree reaches back 1 generation to 2000. 60 later devices descend from it.

Decided: Aug 1, 2003
Review: 121 days
Class: Class II
Product code: HCG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001083 (2000). 60 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK001083 Guglielmi Detachable Coil and Power Supply, Models Power Supply…Boston Scientific, Target · 2000
This deviceK031049 Guglielmi Detachable Coil (GDC)Boston Scientific, Target · 2003
Descendant · cites it directly · 58 of its ownK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
Descendant · 2 generations on · 21 of its ownK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
Descendant · cites it directly · 16 of its ownK103355 GDC 360 Deteachable CoilBoston Scientific Corp · 2011 · Recalled
Descendant · 2 generations on · 16 of its ownK102672 Target Detachable CoilBoston Scientific Corp · 2010
Descendant · 2 generations on · 15 of its ownK123338 Barricade Embolization Coil SystemBlockade Medical · 2013

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2010high 5 (2013) · low 1 (2017)2026

Most influential descendants

Showing 5 of 60 · See all

K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010 · cites it directly58descendants
K103008Inzone Detachment SystemBoston Scientific Corp · 2010 · 2 generations on21descendants
K103355GDC 360 Deteachable CoilBoston Scientific Corp · 2011 · cites it directly16descendants
K102672Target Detachable CoilBoston Scientific Corp · 2010 · 2 generations on16descendants
K123338Barricade Embolization Coil SystemBlockade Medical · 2013 · 2 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001083	Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4…	Boston Scientific, Target	2000	—
0 (this device)	K031049	Guglielmi Detachable Coil (GDC)	Boston Scientific, Target	2003	—
+1	K093142	Target Detachable Coils and Inzone Detachment System	Boston Scientific Corp	2010	—
+2	K103008	Inzone Detachment System	Boston Scientific Corp	2010	—
+1	K103355	GDC 360 Deteachable Coil	Boston Scientific Corp	2011	3
+2	K102672	Target Detachable Coil	Boston Scientific Corp	2010	—
+2	K123338	Barricade Embolization Coil System	Blockade Medical	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2011	4	0
2012	4	0
2013	5	0
2014	5	0
2015	5	0
2016	4	0
2017	1	0
2018	3	0
2019	2	0
2020	3	0
2021	3	0
2022	5	0
2023	1	0
2024	4	0
2025	5	0
2026	3	0

FIG. 1 — Lineage of K031049, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K001083	Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables…	Boston Scientific, Target	2000	—

Also cleared against K001083: 6 other devices →

What descends from it? (60)

See all 60

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

Number	Device	Applicant	Decided	Descendants
K093142	Target Detachable Coils and Inzone Detachment System	Boston Scientific Corp	2010	58
K103355	GDC 360 Deteachable Coil	Boston Scientific Corp	2011	16
K103305	Penumbra Embolization Coil System	Penumbra, Inc.	2011	10

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K093142 (Boston Scientific Corp, 2010) has gone furthest, with 58 descendants of its own.
6 other devices also cite its predicate K001083.

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

2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007high 173 (2018) · low 30 (2012)2026

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

Recalls per year · HCG

1in 2025

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

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

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?

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/K031049 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031049: Guglielmi Detachable Coil (GDC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031049

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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