510(k) · Cleared
ClearedWallaby Avenir Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallaby Medical, Inc. · HCG Device, Neurovascular Embolization
Cleared on May 4, 2018 as substantially equivalent to K162704 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2017) after a 151-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- May 4, 2018
- Review
- 151 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K951256 (1995). 63 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 backK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 2 generations backK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 1 generation backK162704 Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- This deviceK173711 Wallaby Avenir Coil SystemWallaby Medical, Inc. · 2018
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 backK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- 3 generations backK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 2 generations backK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 1 generation backK162704 Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- This deviceK173711 Wallaby Avenir Coil SystemWallaby Medical, Inc. · 2018
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 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| −3 | K133310 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −2 | K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| −1 | K162704 | Axium Prime Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
| 0 (this device) | K173711 | Wallaby Avenir Coil System | Wallaby Medical, Inc. | 2018 | — |
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 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K162704 | Axium Prime Detachable Coil SystemSummary page 4…lass 2, per 21 CFR 882.5950 CLASSIFICATION: PRODUCT CODE HCG, KRD PREDICATE DEVICES: Primary Axium Detachable Coil System, K162704 Reference Microplex Coil System, K102365 Reason for submission: Commercialization… | 2017 |
| † | K102365 | Microplex Coil System- Cosmos | 2010 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 63 ancestors have a recall of any class.
- 2 other devices also cite its predicate K162704.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173711: Wallaby Avenir 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/K173711
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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