510(k) · Cleared
ClearedSundt Slim-Line Graft Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HCH Clip, Aneurysm
Cleared on Mar 10, 1995 after a 1,376-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 10, 1995
- Review
- 1,376 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK912456 Sundt Slim-Line Graft ClipsCodman & Shurtleff, Inc. · 1995
- Descendant · cites it directly · 13 of its ownK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- Descendant · 2 generations on · 8 of its ownK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
- Descendant · 2 generations on · 6 of its ownK984109 Aesculap Axial Clip ApplierAesculap, Inc. · 1999
- Descendant · 2 generations on · 6 of its ownK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
- Descendant · 3 generations on · 4 of its ownK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K955064Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996 · cites it directly13descendants
- K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998 · 2 generations on8descendants
- K984109Aesculap Axial Clip ApplierAesculap, Inc. · 1999 · 2 generations on6descendants
- K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997 · 2 generations on6descendants
- K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912456 | Sundt Slim-Line Graft Clips | Codman & Shurtleff, Inc. | 1995 | — |
| +1 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| +2 | K983758 | Yasargil Titanium Aneurysm Clips | Aesculap, Inc. | 1998 | — |
| +2 | K984109 | Aesculap Axial Clip Applier | Aesculap, Inc. | 1999 | — |
| +2 | K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt) | Aesculap, Inc. | 1997 | — |
| +3 | K131500 | Yasargil Aneurysm Clips and Clip Appliers | Aesculap, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (15)
See all 152 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, K955064 (Elekta Instruments, Inc., 1996) has gone furthest, with 13 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 | — |
https://510kreport.com/device/K912456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912456: Sundt Slim-Line Graft Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912456
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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