510(k) · Cleared
ClearedAneurysm Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gistlstrasse · HCH Clip, Aneurysm
Cleared on Nov 26, 2001 as substantially equivalent to K983758 (Aesculap, Inc., 1998) and 2 other predicates after a 68-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Nov 26, 2001
- Review
- 68 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K772200 (1977). 9 ancestors in all, the oldest K760771 (1976). No later device cites it as a predicate yet.
- Root · 3 generations backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
- 2 generations backK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- 1 generation backK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
- This deviceK013136 Aneurysm ClipsGistlstrasse · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K772200 | Yasargil Aneurysm Clips | Aesculap Instruments Corp. | 1977 | — |
| −2 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| −1 | K983758 | Yasargil Titanium Aneurysm Clips | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K013136 | Aneurysm Clips | Gistlstrasse | 2001 | — |
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 |
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 |
|---|---|---|---|
| * | K983758 | Yasargil Titanium Aneurysm ClipsSummary page 1…5 8010947 Mr. von Zeppelin, President Perneczky Titanium Aneurysm Clips see “Appendix 3" “Aneurysm Clips” Class Il Aneurysm Clip Yasargil Titanium Aneurysm Clips (#K983758) by Aesculap Spetzler Ti 100 Aneurysm Clips (#K955064) by Elekta Sugita Aneurysm clips (#K782040) by Down Surgical, by Mizuho M… | 1998 |
| * | K955064 | Spetzler TI 100 Aneurysm ClipSummary page 1…nium Aneurysm Clips see “Appendix 3" “Aneurysm Clips” Class Il Aneurysm Clip Yasargil Titanium Aneurysm Clips (#K983758) by Aesculap Spetzler Ti 100 Aneurysm Clips (#K955064) by Elekta Sugita Aneurysm clips (#K782040) by Down Surgical, by Mizuho Medical Codman occlusion clips (#K760771) such as Sundt… | 1996 |
| 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 1…ysm Clips” Class Il Aneurysm Clip Yasargil Titanium Aneurysm Clips (#K983758) by Aesculap Spetzler Ti 100 Aneurysm Clips (#K955064) by Elekta Sugita Aneurysm clips (#K782040) by Down Surgical, by Mizuho Medical Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden… | |
| * | K760771 | Sola Schultze-Crock OpthalmoscopeSummary page 1…K983758) by Aesculap Spetzler Ti 100 Aneurysm Clips (#K955064) by Elekta Sugita Aneurysm clips (#K782040) by Down Surgical, by Mizuho Medical Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips. These titanium alloy aneurysm clips will be… | 1976 |
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 24 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K983758.
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 Pemeczky Titanium Aneurysm Clips are devices used to occlude an intracranial aneurysm (a balloon like sac formed on a blood vessel) to prevent it from bleeding or bursting. These titanium alloy aneurysm clips will be available as temporary or permanent devices.
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/K013136 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013136: Aneurysm Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013136
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026