510(k) · Cleared
ClearedCodman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip
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 Sep 8, 2009 as substantially equivalent to K912456 (Codman & Shurtleff, Inc., 1995) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Sep 8, 2009
- Review
- 70 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902544 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902544 Sundt Avm Micro ClipCodman & Shurtleff, Inc. · 1990
- This deviceK091921 Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman…Codman & Shurtleff, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902544 | Sundt Avm Micro Clip | Codman & Shurtleff, Inc. | 1990 | — |
| 0 (this device) | K091921 | Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft… | Codman & Shurtleff, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K912456 | Sundt Slim-Line Graft ClipsSummary page 2…HCH Proposed Device Class: HCH: Class IIper 21 CFR § 882.5200 Clip, Aneurysm Predicate Device(s): K912456 SUNDT SLIM-LINE GRAFT CLIPS K902544 SUNDT AVM MICRO CLIP SYSTEM Device Description: Aneurysm clip… | 1995 |
| * | K902544 | Sundt Avm Micro ClipSummary page 2…§ 882.5200 Clip, Aneurysm Predicate Device(s): K912456 SUNDT SLIM-LINE GRAFT CLIPS K902544 SUNDT AVM MICRO CLIP SYSTEM Device Description: Aneurysm clips have two parts, a spring section and two blades. The spring secti… | 1990 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K912456.
How does its category compare?
All HCH devicesHCH Clip, Aneurysm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm. Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures. Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the…
Read the full statement (162 words)
Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm.
Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle.
Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm.
Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure.
Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091921: Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091921
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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