510(k) · Cleared
ClearedAesculap Axial Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HCI Applier, Aneurysm Clip
Cleared on Feb 12, 1999 as substantially equivalent to K833651 (Advanced Biosearch Assn., 1983) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1977. 6 later devices descend from it.
- Decided
- Feb 12, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- HCI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K772200 (1977). 9 ancestors in all. 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 deviceK984109 Aesculap Axial Clip ApplierAesculap, Inc. · 1999
- 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) | K984109 | Aesculap Axial Clip Applier | Aesculap, Inc. | 1999 | — |
| +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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 HCI? 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 HCI device
- #1 K211572 Aesculap Slim Clip Applierscore 7.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K833651 | Clip Applying ForcepsSummary page 2…unction and intended use as the following clip appliers currently in commercial distribution and cleared by the FDA: « Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651) o Aneurysm Clip Appliers by Aesculap, Inc. (K940970) « Elekta Clip Appliers by Elekta (K955064) 0005 P, & %… | 1983 |
| * | K940970 | Yasargil, Caspar, Vario Clip AppliersSummary page 2…s currently in commercial distribution and cleared by the FDA: « Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651) o Aneurysm Clip Appliers by Aesculap, Inc. (K940970) « Elekta Clip Appliers by Elekta (K955064) 0005 P, & % ii ‘-/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public H… | 1995 |
| * | K955064 | Spetzler TI 100 Aneurysm ClipSummary page 2…leared by the FDA: « Yasargil Clip Applying Forceps by Aesculap, Inc. (K833651) o Aneurysm Clip Appliers by Aesculap, Inc. (K940970) « Elekta Clip Appliers by Elekta (K955064) 0005 P, & % ii ‘-/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ‘% ol Food and Drug Administ… | 1996 |
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 22 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K131500 (Aesculap, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K833651.
How does its category compare?
All HCI devicesHCI Applier, Aneurysm Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HCI
Too few HCI 510(k)s in any year since 2007 to give a median.
Recalls per year · HCI
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCI
1in 2025
MAUDE reports naming product code HCI, 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 | 0 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
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/K984109 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984109: Aesculap Axial Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984109
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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