510(k) · Cleared
Recalled · Class II · 2023D-Clip; D-Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peter Lazic GmbH · HCH Clip, Aneurysm
Cleared on Apr 12, 2019 after a 386-day review. The FDA summary names no predicate by number. It has been recalled 3 times.
- Decided
- Apr 12, 2019
- Review
- 386 days
- Class
- Class II
- Product code
- HCH
- Recalls
- 3
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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 6, 2023 | Class II | Z-1278-2024 | Device Design | Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip. |
| Oct 6, 2023 | Class II | Z-1279-2024 | Device Design | Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip. |
| Oct 6, 2023 | Class II | Z-1277-2024 | Device Design | Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All HCH devicesHCH Clip, Aneurysm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 | — |
https://510kreport.com/device/K180757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180757: D-Clip; D-Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180757
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026