510(k) · Cleared
ClearedAesculap T-Bar Aneurysm Clips (Titanium & Phynox)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HCH Clip, Aneurysm
Cleared on Dec 9, 2004 after a 35-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK043041 Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)Aesculap, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK173271 Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK180914 Aesculap Slim Clip ApplierAesculap, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK211572 Aesculap Slim Clip ApplierAesculap, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK221524 Sugita AVM Microclip ApplierMizuho America, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014 · cites it directly4descendants
- K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc. · 2017 · cites it directly3descendants
- K180914Aesculap Slim Clip ApplierAesculap, Inc. · 2018 · 2 generations on2descendants
- K211572Aesculap Slim Clip ApplierAesculap, Inc. · 2021 · 3 generations on1descendant
- K221524Sugita AVM Microclip ApplierMizuho America, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043041 | Aesculap T-Bar Aneurysm Clips (Titanium & Phynox) | Aesculap, Inc. | 2004 | — |
| +1 | K131500 | Yasargil Aneurysm Clips and Clip Appliers | Aesculap, Inc. | 2014 | — |
| +1 | K173271 | Aesculap Slim Clip Applier Forceps | Aesculap, Inc. | 2017 | — |
| +2 | K180914 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2018 | — |
| +3 | K211572 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2021 | — |
| +4 | K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | — | Aneurysm Clips Named without a submission number |
What descends from it? (5)
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, K131500 (Aesculap, Inc., 2014) has gone furthest, with 4 descendants of its own.
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 T-Bar Aneurysm Clips are intended for occlusion of cerebral
aneurysms in either a temporary or permanent manner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043041: Aesculap T-Bar Aneurysm Clips (Titanium & Phynox).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043041
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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