510(k) Report

510(k) · Cleared

Cleared

Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS Detachable Coil System

K014041510(k) TraditionalCleared Mar 7, 200290-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

Cordis Neurovascular · HCG Device, Neurovascular Embolization

Cleared on Mar 7, 2002 as substantially equivalent to K951256 (Target Therapeutics, 1995) and 9 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1995.

Decided
Mar 7, 2002
Review
90 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
10

Its longest line of descent runs back 5 generations to K951256 (1995). 31 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 5 other ancestors1997: 1 other ancestor1996: 2 other ancestors1995: 2 other ancestors1994: 3 other ancestors1992: 5 other ancestors1991: 2 other ancestors1990: 1 other ancestor1989: 1 other ancestor1988: 3 other ancestors1986: 1 other ancestorK951256 · Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) · Target Therapeutics · 1995K960705 · Guglielmi Detachable Coil · Target Therapeutics · 1996K962503 · Guglielmi Detachable Coil · Target Therapeutics · 1996K971395 · Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce · Target Therapeutics · 1997K991139 · Guglielmi Detachable (GDC) · Boston Scientific, Target · 19991985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 20 other ancestors3 generations back: 1 other ancestor K991139 · Guglielmi Detachable (GDC) · Boston Scientific, Target · 1999K971395 · Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce · Target Therapeutics · 1997K962503 · Guglielmi Detachable Coil · Target Therapeutics · 1996K960705 · Guglielmi Detachable Coil · Target Therapeutics · 1996K951256 · Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) · Target Therapeutics · 1995−50
  1. Root · 5 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
  2. 4 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
  3. 3 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
  4. 2 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  5. 1 generation backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  6. This deviceK014041 Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as…Cordis Neurovascular · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K951256Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics1995—
−4K960705Guglielmi Detachable CoilTarget Therapeutics1996—
−3K962503Guglielmi Detachable CoilTarget Therapeutics1996—
−2K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
−1K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
0 (this device)K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill…Cordis Neurovascular2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198830
198910
199010
199120
199250
199430
199520
199620
199710
200050
FIG. 1 — Lineage of K014041, 1995–2002Source: 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), 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. #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? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K951256Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)
Summary page 3
…10(k) Summary of Safety and Effectiveness, Continued Predicate Devices The predicate device is listed in the table below. Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K9934…
Target Therapeutics1995—
*K960705Guglielmi Detachable Coil
Summary page 3
…ctiveness, Continued Predicate Devices The predicate device is listed in the table below. Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The T…
Target Therapeutics1996—
*K962503Guglielmi Detachable Coil
Summary page 3
…edicate Devices The predicate device is listed in the table below. Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable C…
Target Therapeutics1996—
*K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…
Summary page 3
…device is listed in the table below. Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the…
Target Therapeutics1997—
*K991139Guglielmi Detachable (GDC)
Summary page 3
…e table below. Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Descript…
Boston Scientific, Target1999—
*K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…
Summary page 3
…below. Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Description Deta…
Boston Scientific, Target2000—
*K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…
Summary page 3
…Guglielmi Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Description Detachable C…
Boston Scientific, Target2000—
*K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil
Summary page 3
…i Detachable Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Description Detachable Coil and…
Boston Scientific, Target20001
*K001083Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables…
Summary page 3
…able Coil Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Description Detachable Coil and TRUFILL®…
Boston Scientific, Target2000—
*K002181GDC Ultrasoft Coil
Summary page 3
…l Boston Scientific, K951256 HCG Embolic coil Target K960705 Delivery system K962503 Detachment mechanism K971395 Sterilization K991139 K993415 K993417 K993418 K001083 K002181 Device The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Description Detachable Coil and TRUFILL® DCS Syr…
Boston Scientific, Target2000—

Also cleared against K951256: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • 4 of the 31 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K951256.

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—

What is it indicated for?

The TRUFILL® DCS Detachable Coil System 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…

Read the full statement (99 words)

The TRUFILL® DCS Detachable Coil System 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 TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the

peripheral vasculature.

The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS Detachable Coil.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K951256

7 other devices cite the same predicate.

  • K031810Amplatzer Vascular PlugAga Medical Corp. · 20031 recall
  • K012145Microplex Coil SystemMicroVention, Inc. · 2001
  • K993455Flipper Detachable Embolization CoilCook, Inc. · 2000
  • K992121Embolization Coil SystemCook, Inc. · 1999
  • K963307GDC Patient Return Electtrode Model 45021Target Therapeutics · 1996
  • K962503Guglielmi Detachable CoilTarget Therapeutics · 1996

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/K014041 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014041: Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014041

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026