510(k) · Cleared
ClearedSundt Avm Micro Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HCI Applier, Aneurysm Clip
Cleared on Sep 20, 1990 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 20, 1990
- Review
- 106 days
- Class
- Class II
- Product code
- HCI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK902544 Sundt Avm Micro ClipCodman & Shurtleff, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK960037 Sugita Avm MicroclipMizuho America, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK211183 Sugita AVM MicroclipsMizuho America, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK091921 Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman…Codman & Shurtleff, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K960037Sugita Avm MicroclipMizuho America, Inc. · 1997 · cites it directly1descendant
- K211183Sugita AVM MicroclipsMizuho America, Inc. · 2022 · 2 generations on0descendants
- K091921Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft…Codman & Shurtleff, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902544 | Sundt Avm Micro Clip | Codman & Shurtleff, Inc. | 1990 | — |
| +1 | K960037 | Sugita Avm Microclip | Mizuho America, Inc. | 1997 | — |
| +2 | K211183 | Sugita AVM Microclips | Mizuho America, Inc. | 2022 | — |
| +1 | K091921 | Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft… | Codman & Shurtleff, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K960037 (Mizuho America, Inc., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HCI devicesHCI Applier, Aneurysm Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K902544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902544: Sundt Avm Micro Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902544
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026