510(k) · Cleared
ClearedTarget 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 Nov 30, 2012 as substantially equivalent to K102672 (Boston Scientific Corp, 2010) and 2 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1995. 12 later devices descend from it.
- Decided
- Nov 30, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K951256 (1995). 37 ancestors in all, the oldest K860840 (1986). 12 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations between
- 3 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 2 generations backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- 1 generation backK113412 Target Detachable CoilStryker Neurovascular · 2011 · Recalled
- This deviceK123377 Target Detachable CoilStryker Neurovascular · 2012
- Descendant · cites it directly · 11 of its ownK153658 Target Detachable CoilsStryker Neurovascular · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK161429 Target Detachable CoilsStryker Neurovascular · 2016
- Descendant · 2 generations on · 3 of its ownK222533 Target Tetra Detachable CoilsStryker Neurovascular · 2022
- Descendant · 3 generations on · 3 of its ownK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK242243 Target Detachable CoilsStryker Neurovscular · 2024
Show all 11 generations
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 7 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 6 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 5 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 4 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 3 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 2 generations backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- 1 generation backK113412 Target Detachable CoilStryker Neurovascular · 2011 · Recalled
- This deviceK123377 Target Detachable CoilStryker Neurovascular · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K153658Target Detachable CoilsStryker Neurovascular · 2016 · cites it directly11descendants
- K161429Target Detachable CoilsStryker Neurovascular · 2016 · 2 generations on10descendants
- K222533Target Tetra Detachable CoilsStryker Neurovascular · 2022 · 2 generations on3descendants
- K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021 · 3 generations on3descendants
- K242243Target Detachable CoilsStryker Neurovscular · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −10 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −7 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −6 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −5 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −4 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −3 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| −2 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
| −1 | K113412 | Target Detachable Coil | Stryker Neurovascular | 2011 | 28 |
| 0 (this device) | K123377 | Target Detachable Coil | Stryker Neurovascular | 2012 | — |
| +1 | K153658 | Target Detachable Coils | Stryker Neurovascular | 2016 | 28 |
| +2 | K161429 | Target Detachable Coils | Stryker Neurovascular | 2016 | — |
| +2 | K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022 | — |
| +3 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021 | — |
| +2 | K242243 | Target Detachable Coils | Stryker Neurovscular | 2024 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102672 | Target Detachable CoilSummary page 2…ness (cant.) Legally Marketed Predicate Devices: Reference (Clearance Date) Device K102672 (15 October 2010) Target Detachable Coil K(112385 (15 September 2011) Target Detac… | 2010 |
| * | K112385 | Traget Detachable CoilSummary page 4…Page 3 of 6 510(k) Summary Of Safety And Effectiveness (cant.) Predicate Device Testing (from K112385) 1)Functional Testing to assess: a) Coil / Catheter Compatibility… | 2011 |
| * | K113412 | Target Detachable CoilSummary page 5…Page 4 of 6 510(k) Summary Of Safety And Effectiveness (cant.) Predicate Device Testing (from K113412) 1)Functional Testing to assess: a) Main Junction Tensile Strength… | 2011 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153658 | Target Detachable Coils | 2016 | 11 |
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 17 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 8 of the 37 ancestors have a recall of any class.
- Of its descendants, K153658 (Stryker Neurovascular, 2016) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K102672.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 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 endlovascular 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/K123377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123377: Target Detachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123377
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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