510(k) · Cleared
ClearedMicrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356); Micrusframe (MFR100407); Micrusframe (MFR100412); Micrusframe (MFR100509); Micrusframe (MFR100517); Micrusframe (MFR100611); Micrusframe (MFR100626); Micrusframe (MFR100713); Micrusframe (MFR100730); Micrusframe (MFR100816); Micrusframe (MFR100829); Micrusframe (MFR140225); Micrusframe (MFR140303); Micrusframe (MFR140304); Micrusframe (MFR140306); Micrusframe (MFR140406); Micrusframe (MF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerenovus, Inc. · HCG Device, Neurovascular Embolization
Cleared on Aug 14, 2026 as substantially equivalent to K211344 (Medos International SARL, 2021) after a 30-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Aug 14, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K951256 (1995). 57 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 15 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations between
- 3 generations backK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
- 2 generations backK171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System…Codman & Shurtleff, Inc. · 2017
- 1 generation backK211344 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and…Medos International SARL · 2021
- This deviceK262419 Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe…Cerenovus, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 14 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 13 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 12 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 11 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 10 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 9 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 8 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 7 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 6 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 5 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 4 generations backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- 3 generations backK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
- 2 generations backK171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System…Codman & Shurtleff, Inc. · 2017
- 1 generation backK211344 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and…Medos International SARL · 2021
- This deviceK262419 Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe…Cerenovus, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −14 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −13 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −12 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −11 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −10 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −9 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −8 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −7 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −6 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| −5 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| −4 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
| −3 | K150319 | Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch… | Codman & Shurtleff, Inc. | 2015 | — |
| −2 | K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18… | Codman & Shurtleff, Inc. | 2017 | — |
| −1 | K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3… | Medos International SARL | 2021 | — |
| 0 (this device) | K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305)… | Cerenovus, Inc. | 2026 | — |
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 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Summary page 8…Microcoil Delivery System, DELTAXSFT Microcoil Delivery Primary K211344 May 28, 2021 System, GALAXY G3 Microcoil Cerenovus, Inc.… | 2021 |
| † | K242582 | Optima Coil System (OptiBlock Line Extension) | 2024 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 57 ancestors have a recall of any class.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the…
Read the full statement (182 words)
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 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 vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
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/K262419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262419: Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356); Micrusframe (MFR100407); Micrusframe (MFR100412); Micrusframe (MFR100509); Micrusframe (MFR100517); Micrusframe (MFR100611); Micrusframe (MFR100626); Micrusframe (MFR100713); Micrusframe (MFR100730); Micrusframe (MFR100816); Micrusframe (MFR100829); Micrusframe (MFR140225); Micrusframe (MFR140303); Micrusframe (MFR140304); Micrusframe (MFR140306); Micrusframe (MFR140406); Micrusframe (MF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262419
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026