510(k) · Cleared
Recalled · Class II · 2016Target Detachable Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · HCG Device, Neurovascular Embolization
Cleared on Dec 13, 2011 as substantially equivalent to K093142 (Boston Scientific Corp, 2010) and 2 other predicates after a 25-day review. Its family tree reaches back 10 generations to 1995. 13 later devices descend from it. It has been recalled 28 times.
- Decided
- Dec 13, 2011
- Review
- 25 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 28
- Predicates
- 3
Its longest line of descent runs back 10 generations to K951256 (1995). 36 ancestors in all, the oldest K860840 (1986). 13 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 6 generations between
- 3 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 1 generation backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- This deviceK113412 Target Detachable CoilStryker Neurovascular · 2011
- Descendant · cites it directly · 12 of its ownK123377 Target Detachable CoilStryker Neurovascular · 2012
- Descendant · 2 generations on · 11 of its ownK153658 Target Detachable CoilsStryker Neurovascular · 2016 · Recalled
- Descendant · 3 generations on · 10 of its ownK161429 Target Detachable CoilsStryker Neurovascular · 2016
- Descendant · 3 generations on · 3 of its ownK222533 Target Tetra Detachable CoilsStryker Neurovascular · 2022
- Descendant · 4 generations on · 3 of its ownK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 9 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 7 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 6 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 5 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 4 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 3 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 1 generation backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- This deviceK113412 Target Detachable CoilStryker Neurovascular · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
2012high 3 (2024) · low 0 (2013)2026
Most influential descendants
Showing 5 of 13 · See all- K123377Target Detachable CoilStryker Neurovascular · 2012 · cites it directly12descendants
- K153658Target Detachable CoilsStryker Neurovascular · 2016 · 2 generations on11descendants
- K161429Target Detachable CoilsStryker Neurovascular · 2016 · 3 generations on10descendants
- K222533Target Tetra Detachable CoilsStryker Neurovascular · 2022 · 3 generations on3descendants
- K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −9 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −7 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −6 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −5 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −4 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −3 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −2 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| −1 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
| 0 (this device) | K113412 | Target Detachable Coil | Stryker Neurovascular | 2011 | — |
| +1 | K123377 | Target Detachable Coil | Stryker Neurovascular | 2012 | — |
| +2 | K153658 | Target Detachable Coils | Stryker Neurovascular | 2016 | 28 |
| +3 | K161429 | Target Detachable Coils | Stryker Neurovascular | 2016 | — |
| +3 | K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022 | — |
| +4 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K093142 | Target Detachable Coils and Inzone Detachment SystemSummary page 2…f qi Dvics:Reference (Clearance Date) Preicae Device K093 142 (4 February 20 10) Target Detachable Coil and InZone® Detachment Sys… | 2010 |
| * | K102672 | Target Detachable CoilSummary page 2…093 142 (4 February 20 10) Target Detachable Coil and InZone® Detachment System K102672 (15 October 20 10) Target Detachable Coil KI 12385 (15 September 2011) Target Detachable Coil… | 2010 |
| * | K112385 | Traget Detachable Coil | 2011 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123377 | Target Detachable Coil | 2012 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2016 | Class II | Z-2171-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2179-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2175-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2167-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2168-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2184-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2180-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2164-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2186-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2177-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2163-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2165-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2172-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2170-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2173-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2160-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2182-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2183-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2176-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2161-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2187-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2181-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2178-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2185-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2169-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2174-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2162-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
| Jun 6, 2016 | Class II | Z-2166-2016 | Process change control | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can… |
The 5 latest of 28 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 7 of the 36 ancestors have a recall of any class.
- Of its descendants, K123377 (Stryker Neurovascular, 2012) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K093142.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
Target Detachable Coils are indicated 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/K113412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113412: Target 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/K113412
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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