510(k) · Cleared
ClearedYasargil Titanium Aneurysm Clips (Ftxxxt)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HCH Clip, Aneurysm
Cleared on Nov 26, 1997 as substantially equivalent to K955064 (Elekta Instruments, Inc., 1996) and 1 other predicate after a 324-day review. Its family tree reaches back 2 generations to 1977. 6 later devices descend from it.
- Decided
- Nov 26, 1997
- Review
- 324 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K772200 (1977). 8 ancestors in all, the oldest K760771 (1976). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
- 1 generation backK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- This deviceK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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 |
|---|---|---|---|---|---|
| −2 | K772200 | Yasargil Aneurysm Clips | Aesculap Instruments Corp. | 1977 | — |
| −1 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| 0 (this device) | K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt) | Aesculap, Inc. | 1997 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1979 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955064 | Spetzler TI 100 Aneurysm ClipSummary page 2…biocompatibilty study conducted on the titanium Spetzler Ti 160 Aneurysm Clips which have received marketing clearance from the Food and Drug Administration (subject to #K955064). E. Mechanical llurgical and MRI Testing of the Final Pr Studies done on the various stages in the production of the clips usin… | 1996 |
| * | K760771 | Sola Schultze-Crock OpthalmoscopeSummary page 3…loy aneurysm clips share similar features, dimensions and styles to Spetzler Ti 100 Aneurysm Clips, (subject to #K955064) by Elekta Instruments, Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips as well as to Sugita Aneurysm clips (subject… | 1976 |
| Kept off the family tree | K782040 | Sugita Aneurysm clips Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3…ts, Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips as well as to Sugita Aneurysm clips (subject to #K782040) by Downs Surgical, manufactured by Mizuho Medical Co. Ltd. 007 Public Health Service Food and Drug Administrat… | |
| * | — | Yasargil Phynox aneurysm clips Named without a submission number |
What descends from it? (6)
3 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K131500 (Aesculap, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K955064.
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 Yasargil Titanium Aneurysm Clips presented in this submission are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.
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/K970050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970050: Yasargil Titanium Aneurysm Clips (Ftxxxt).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970050
Report an extraction error
Are you the manufacturer?
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