510(k) · Cleared
ClearedStorz Raney Scalp Clip, Model 1-20-004-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rudolf Storz GmbH · HBO Clip, Scalp
Cleared on Jan 7, 2004 after a 47-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 7, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- HBO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBO? 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 HBO device
- #1 K253814 Raney Clips Kitscore 12.0 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All HBO devicesHBO Clip, Scalp: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBO
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HBO
Too few HBO 510(k)s in any year since 2007 to give a median.
Recalls per year · HBO
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBO
4in 2025
MAUDE reports naming product code HBO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 1 | 12 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The STORZ Raney Scalp Clip is a device designed to stop bleeding during surgery on the scalp.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033660: Storz Raney Scalp Clip, Model 1-20-004-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033660
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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