510(k) · Cleared
ClearedOrbit Galaxy G2 Microcoil Delivery System
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 Apr 4, 2012 as substantially equivalent to K072173 (Micrus Endovascular Corporation, 2007) and 1 other predicate after a 29-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Apr 4, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K951256 (1995). 36 ancestors in all, the oldest K860840 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 6 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 4 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 3 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 2 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 1 generation backK072173 Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR…Micrus Endovascular Corporation · 2007 · Recalled
- This deviceK120686 Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK142429 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery…Codman & Shurtleff, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −7 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −6 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −4 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −3 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −2 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −1 | K072173 | Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRC | Micrus Endovascular Corporation | 2007 | 1 |
| 0 (this device) | K120686 | Orbit Galaxy G2 Microcoil Delivery System | Codman & Shurtleff, Inc. | 2012 | — |
| +1 | 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 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K072173 | Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCSummary page 1…Number/.. tone -Date. Micrus Microcoil Codman & Shurtleff, Inc K072173 Intended Use System, (Previously Micrus HCG Design CASHMERE®I SR… | 2007 |
| * | K093973 | Trufill DCS Orbit Detachable Coil SystemSummary page 1…Manufacturing (Primary predicate) Sterilization ORBIT GALAXY®' Codman & Shurtleff, Inc K093973 Intended Use Detachable Coil (5/26/20 10) HCG Design System… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2… | 2014 | 0 |
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 5 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K142429 (Codman & Shurtleff, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072173.
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?
The Fill Orbit Galaxy® G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120686: Orbit Galaxy G2 Microcoil Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120686
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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