510(k) Report

510(k) · Cleared

Cleared

Helix Shaped Coils with Dacron Fibers, Modified

K911779510(k) TraditionalCleared Nov 8, 1991210-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

Target Therapeutics · HCG Device, Neurovascular Embolization

Cleared on Nov 8, 1991 after a 210-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 154 devices in its family, counting itself, has a Class I recall. 153 later devices descend from it.

Decided
Nov 8, 1991
Review
210 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
0

153 later devices descend from it, 2 citing it directly. 1 of the 154 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2004: 4 descendants cleared2014: 8 descendants cleared2002: 6 descendants cleared2000: 3 descendants cleared1999: 1 descendant cleared2001: 1 descendant cleared2003: 3 descendants cleared2006: 1 descendant cleared2010: 7 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2008: 8 descendants cleared2005: 3 descendants cleared2011: 9 descendants cleared2013: 11 descendants cleared2017: 6 descendants cleared2012: 11 descendants cleared2015: 8 descendants cleared2020: 3 descendants cleared2016: 7 descendants cleared2018: 5 descendants cleared2022: 7 descendants cleared, 1 with a Class I recall12019: 2 descendants cleared2021: 6 descendants cleared2024: 4 descendants cleared2025: 5 descendants cleared2023: 2 descendants cleared2026: 6 descendants cleared1990200020102020
  1. This deviceK911779 Helix Shaped Coils with Dacron Fibers, ModifiedTarget Therapeutics · 1991
  2. Descendant · cites it directly · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  3. Descendant · 2 generations on · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  4. Descendant · 2 generations on · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
  5. Descendant · 3 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
  6. Descendant · 2 generations on · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12000: 32001: 12002: 62003: 32004: 42005: 32006: 12007: 52008: 82009: 102010: 72011: 92012: 112013: 112014: 82015: 82016: 72017: 62018: 52019: 22020: 32021: 62022: 72023: 22024: 42025: 52026: 6
1997high 11 (2012) · low 0 (1998)2026

Class I recalls in this family

  • K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…7 generations on · 2022

Most influential descendants

Showing 5 of 153 · See all
  • K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · cites it directly150descendants
  • K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · 2 generations on138descendants
  • K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · 2 generations on105descendants
  • K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 3 generations on103descendants
  • K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · 2 generations on98descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911779Helix Shaped Coils with Dacron Fibers, ModifiedTarget Therapeutics1991—
+1K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
+2K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
+2K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch…Boston Scientific, Target2000—
+3K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002—
+2K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi…Boston Scientific, Target2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200030
200110
200260
200330
200440
200530
200610
200750
200880
2009100
201070
201190
2012110
2013110
201480
201580
201670
201760
201850
201920
202030
202160
202271
202320
202440
202550
202660
FIG. 1 — Lineage of K911779, 1991–2026Source: 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
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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? (153)

See all 153

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

NumberDeviceApplicantDecidedDescendants
K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150
K040342Interlocking Detachable Coil System (Idc)Boston Scientific Corp20041

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 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K971395 (Target Therapeutics, 1997) has gone furthest, with 150 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 Target Therapeutics

70 FDA decisions under this applicant name. See the company

  • K965071Detachable Slicone Balloon (DSB)Target Therapeutics · 1998
  • K964488Detachable Silicone Balloon (DSB)Target Therapeutics · 1998
  • K964210Retriever IITarget Therapeutics · 1997
  • K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum…Target Therapeutics · 1997
  • K965189SpinnakerTarget Therapeutics · 1997

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/K911779 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911779: Helix Shaped Coils with Dacron Fibers, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911779

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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