510(k) · Cleared
ClearedTrufill DCS Orbit Detachable Coil 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 May 26, 2010 as substantially equivalent to K080967 (Cordis Neurovascular, Inc., 2008) after a 153-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- May 26, 2010
- Review
- 153 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080967 (2008). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK080967 Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill…Cordis Neurovascular, Inc. · 2008
- This deviceK093973 Trufill DCS Orbit Detachable Coil SystemCodman & Shurtleff, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK120686 Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK142429 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery…Codman & Shurtleff, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS… | Cordis Neurovascular, Inc. | 2008 | — |
| 0 (this device) | K093973 | Trufill DCS Orbit Detachable Coil System | Codman & Shurtleff, Inc. | 2010 | — |
| +1 | K120686 | Orbit Galaxy G2 Microcoil Delivery System | Codman & Shurtleff, Inc. | 2012 | — |
| +2 | K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT… | Codman & Shurtleff, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II…Summary page 1…Date _ _ _ _ _ _ _ _ _ _ _ _ _ TRUFILL® DCS Codman & K080967/I HCG Intended Use ORBIT TM Shurtleff, 5-02-08… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120686 | Orbit Galaxy G2 Microcoil Delivery System | 2012 | 1 |
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?
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
1) The XTRASOFTTM ORBIT GALAXYTM Detachable Coil is indicated for embolizing intracranial aneurysms.
2) The Fill ORBIT GALAXYTM Detachable Coil and the Frame ORBIT GALAXYTM Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The Fill ORBIT GALAXYTM Detachable Coil and the Frame ORBIT GALAXYTM Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093973: Trufill DCS Orbit Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093973
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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