510(k) · Cleared
ClearedSugita AVM Microclip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mizuho America, Inc. · HCI Applier, Aneurysm Clip
Cleared on Jun 24, 2022 as substantially equivalent to K211572 (Aesculap, Inc., 2021) after a 29-day review. Its family tree reaches back 7 generations to 1977.
- Decided
- Jun 24, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- HCI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K772200 (1977). 22 ancestors in all, the oldest K760771 (1976). No later device cites it as a predicate yet.
- Root · 7 generations backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
- 6 generations backK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- 5 generations backK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
- 4 generations backK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
- 3 generations backK173271 Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017
- 2 generations backK180914 Aesculap Slim Clip ApplierAesculap, Inc. · 2018
- 1 generation backK211572 Aesculap Slim Clip ApplierAesculap, Inc. · 2021
- This deviceK221524 Sugita AVM Microclip ApplierMizuho America, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K772200 | Yasargil Aneurysm Clips | Aesculap Instruments Corp. | 1977 | — |
| −6 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| −5 | K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt) | Aesculap, Inc. | 1997 | — |
| −4 | K131500 | Yasargil Aneurysm Clips and Clip Appliers | Aesculap, Inc. | 2014 | — |
| −3 | K173271 | Aesculap Slim Clip Applier Forceps | Aesculap, Inc. | 2017 | — |
| −2 | K180914 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2018 | — |
| −1 | K211572 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2021 | — |
| 0 (this device) | K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 HCI? 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 HCI device
- #1 K211572 Aesculap Slim Clip Applierscore 7.0 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K211572 | Aesculap Slim Clip ApplierSummary page 4…neurysm Clip Applier Regulation number: 882.4175 Product Code: HCI Predicate Device: Aesculap Slim Clip Applier (K211572). Reference Device: Sugita AVM Microclip (K960037). Device Modification: The following changes have been made to the Su… | 2021 |
| † | K960037 | Sugita Avm Microclip | 1997 |
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 45 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 22 ancestors has a recall of any class.
How does its category compare?
All HCI devicesHCI Applier, Aneurysm Clip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HCI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HCI
Too few HCI 510(k)s in any year since 2007 to give a median.
Recalls per year · HCI
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCI
1in 2025
MAUDE reports naming product code HCI, 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 | 0 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.
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/K221524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221524: Sugita AVM Microclip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221524
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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