510(k) · Cleared
Recalled · Class II · 2013Sugita Titanium Aneurysm Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mizuho America, Inc. · HCH Clip, Aneurysm
Cleared on Jun 4, 1999 as substantially equivalent to K970050 (Aesculap, Inc., 1997) and 2 other predicates after a 134-day review. Its family tree reaches back 3 generations to 1977. It has been recalled 2 times.
- Decided
- Jun 4, 1999
- Review
- 134 days
- Class
- Class II
- Product code
- HCH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K772200 (1977). 10 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 backK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
- This deviceK990202 Sugita Titanium Aneurysm ClipMizuho America, Inc. · 1999
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 | K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt) | Aesculap, Inc. | 1997 | — |
| 0 (this device) | K990202 | Sugita Titanium Aneurysm Clip | Mizuho America, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1979 | 1 | 0 |
| 1983 | 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? (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 |
|---|---|---|---|
| * | K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt)Summary page 1…9 A. LEGALLY MARKETED PREDICATE DEVICES The Sugita Titanium Aneurysm Clip is substantially equivalent to the Aesculap Titanium Aneurysm Clip which was cleared by FDA as K970050 on November 26, 1997. It is also substantially equivalent in some characteristics to the Sugita (Elgiloy) Aneurysm Clip, cleared… | 1997 |
| * | P820009 | Lincoff-Design Scleral Buckling Balloon CatheterSummary page 1…ed by FDA as K970050 on November 26, 1997. It is also substantially equivalent in some characteristics to the Sugita (Elgiloy) Aneurysm Clip, cleared for marketing under P820009 as a Class lll device and reclassified into Class Il on May 18, 1983, and to the Spetzler Ti-100 Titanium Aneurysm Clip cleared b… | 1983 |
| * | K955064 | Spetzler TI 100 Aneurysm ClipSummary page 1…red for marketing under P820009 as a Class lll device and reclassified into Class Il on May 18, 1983, and to the Spetzler Ti-100 Titanium Aneurysm Clip cleared by FDA as K955064 on October 17, 1996. B. DEVICE DESCRIPTION The Sugita Titanium Aneurysm Clip is made from the titanium alloy Ti6Al4V. This allo… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2013 | Class II | Z-0378-2014 | Process control | Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored. |
| Oct 10, 2013 | Class II | Z-0377-2014 | Process control | Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K970050.
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 Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.
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/K990202 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990202: Sugita Titanium Aneurysm Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990202
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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