510(k) · Cleared
Recalled · Class II · 2018Medtronic Clip Gun Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · HBO Clip, Scalp
Cleared on Feb 7, 2005 as substantially equivalent to K896723 (Omni Medical Designs, 1990) after a 28-day review. Its family tree reaches back 1 generation to 1990. It has been recalled 2 times.
- Decided
- Feb 7, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- HBO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896723 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896723 Clip Gun with Raney Type Scalp ClipsOmni Medical Designs · 1990
- This deviceK050044 Medtronic Clip Gun KitMedtronic Neurosurgery · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896723 | Clip Gun with Raney Type Scalp Clips | Omni Medical Designs | 1990 | — |
| 0 (this device) | K050044 | Medtronic Clip Gun Kit | Medtronic Neurosurgery | 2005 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K896723 | Clip Gun with Raney Type Scalp ClipsSummary page 1…ensing Gun; Raney Type Scalp Clips ( 882.4150) Predicate Device Identification: Clip Gun with Raney Type Scalp Clips (K896723) Description: The Clip Gun Kit contains Raney-type clips intended to provide hemnostasis during cranial surgery by preventing… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2018 | Class II | Z-3212-2018 | Under Investigation by firm | The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is… |
| Dec 20, 2017 | Class II | Z-0622-2018 | Package design/selection | Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no 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 Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing arterial bleeding from small vessels of the skin and deeper vessels under the scalp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050044: Medtronic Clip Gun Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050044
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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