510(k) · Cleared
ClearedCODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HCG Device, Neurovascular Embolization
Cleared on Dec 24, 2014 as substantially equivalent to K082739 (Micrus Endovascular Corporation, 2008) and 8 other predicates after a 117-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Dec 24, 2014
- Review
- 117 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 12 generations to K951256 (1995). 58 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 8 generations between
- 3 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 2 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 1 generation backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- This deviceK142429 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery…Codman & Shurtleff, Inc. · 2014
Show all 12 generations
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 10 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 8 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 7 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 6 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 5 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 4 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 3 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 2 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 1 generation backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- This deviceK142429 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery…Codman & Shurtleff, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −11 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −10 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −8 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −7 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −6 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −5 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −4 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −3 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| −2 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| −1 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
| 0 (this device) | K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT… | Codman & Shurtleff, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (9)
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 |
|---|---|---|---|
| * | K082739 | Micrus Microcoil Delivery SystemSummary page 4…Micrus Microcoil Delivery System Micrus Endovascular 10/17/2008 K082739 (Includes Cables) Corporation*… | 2008 |
| * | K083646 | Micrus Microcoli System, Deltaplush, Models CPL, DPLSummary page 4…Micrus Endovascular 01/02/2009 and DELTAPLUSH 10 Cerecyte CPL K083646 Corporation*… | 2009 |
| * | K120686 | Orbit Galaxy G2 Microcoil Delivery SystemSummary page 4…il 04/04/2012 Codman & Shurtleff, Inc. K120686 Delivery System (Includes Cables) Predicate… | 2012 |
| * | K120274 | Deltamaxx 18 Microcoil SystemSummary page 4…em 03/02/2012 Codman & Shurtleff, Inc. K120274 (Includes Cables) Predicate… | 2012 |
| * | K072173 | Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCSummary page 4…Micrus Endovascular 10/05/2007 Micrus Microcoil System “Cashmere” K072173 Corporation* Predi… | 2007 |
| * | K073442 | Micrus Microcoil SystemsSummary page 4…Micrus Endovascular 02/26/2008 Micrus Microcoil Delivery System K073442 Corporation* Predi… | 2008 |
| * | K032872 | Micrus Microcoil SystemSummary page 4…ration* Predicate 11/28/2003 Micrus Microcoil Delivery System Long Micrus Endovascular K032872 Spherical Coils Corporation* Predi… | 2003 |
| * | K062036 | Micrus Microcoil System Presidio-18, Model PC4Summary page 4…ration* Predicate 08/25/2006 Micrus Microcoil Delivery System Micrus Endovascular K062036 Presidio-18 Corporation* Predi… | 2006 |
| * | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheSummary page 4…ration* Predicate 12/07/2005 Micrus Microcoil Delivery System Micrus Endovascular K053160 Cerecyte-18 Corporation* *… | 2005 |
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 19 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 8 of the 58 ancestors have a recall of any class.
- 1 other device also cites its predicate K082739.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature. The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous…
Read the full statement (126 words)
CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142429: CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142429
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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