510(k) · Cleared
ClearedAesculap Yasargil Aneurysm Clip Phynox Booster Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HCH Clip, Aneurysm
Cleared on Aug 20, 2003 after a 33-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 20, 2003
- Review
- 33 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HCH? 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 HCH device
- #1 K211183 Sugita AVM Microclipsscore 3.2 · 2 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 |
|---|---|---|---|
| * | — | Yasargil Aneurysm Clip Titanium Booster Clip Named without a submission number |
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.
How does its category compare?
All HCH devicesHCH Clip, Aneurysm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCH
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HCH
Too few HCH 510(k)s in any year since 2007 to give a median.
Recalls per year · HCH
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCH
2in 2025
MAUDE reports naming product code HCH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 2 | 3 |
| 2014 | 1 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032198 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032198: Aesculap Yasargil Aneurysm Clip Phynox Booster Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032198
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026