510(k) · Cleared
Recalled · 2007Matrix Stretch Resistant (SR) Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · HCG Device, Neurovascular Embolization
Cleared on Apr 15, 2005 as substantially equivalent to K031168 (Boston Scientific, Target, 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1995. 59 later devices descend from it. It has been recalled once.
- Decided
- Apr 15, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K951256 (1995). 29 ancestors in all, the oldest K860840 (1986). 59 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 2 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 1 generation backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- This deviceK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005
- 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 · 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
- Descendant · 2 generations on · 15 of its ownK112385 Traget Detachable CoilStryker Neurovascular · 2011
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010 · cites it directly58descendants
- K103008Inzone Detachment SystemBoston Scientific Corp · 2010 · 2 generations on21descendants
- K102672Target Detachable CoilBoston Scientific Corp · 2010 · 2 generations on16descendants
- K123338Barricade Embolization Coil SystemBlockade Medical · 2013 · 2 generations on15descendants
- K112385Traget Detachable CoilStryker Neurovascular · 2011 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −5 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −1 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| 0 (this device) | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | — |
| +1 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +2 | K103008 | Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +2 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| +2 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +2 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
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 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 3 | 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 |
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 |
|---|---|---|---|
| * | K031168 | Matrix Stretch Resistant Detachable CoilSummary page 1…tion Device (21 CFR Section 882.5950) Predicate Devices Number Description Predicate for Clearance Date K031168 Matrix Stretch Resistant Matrix 2 Stretch Resistant 14 May 2003 (Boston Detachable Coils… | 2003 |
| * | K012985 | Matrix Detachable CoilsSummary page 2…Boston Scientific Neurovascular's Matrix2 Detachable Coils Number Description Predicate for Clearance Date K012985 Matrix Detachable Coils Matrix 2 12D Firm Coils… | 2002 |
| * | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilSummary page 2…a Matrix 2 3D Omega Standard · Matrix 2 Omega Firm K042539 GDC 3600 Coils Matrix 2 3600 Coils: 19 October 2004 (Boston… | 2004 |
What descends from it? (59)
See all 591 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093142 | Target Detachable Coils and Inzone Detachment System | 2010 | 58 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2007 | Not classified | Z-0668-2007 | Other | The product may be missing the temperature indicator label on the inner pouch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 6 of the 29 ancestors have a recall of any class.
- Of its descendants, K093142 (Boston Scientific Corp, 2010) has gone furthest, with 58 descendants of its own.
- 1 other device also cites its predicate K031168.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Matrix 2 Detachable Coils are 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.
Matrix2 Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050700: Matrix Stretch Resistant (SR) Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050700
Report an extraction error
Are you the manufacturer?
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