# K050044: Medtronic Clip Gun Kit

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Feb 7, 2005 after 28 days
- Product code: HBO (Clip, Scalp)
- Device class: 2
- Regulation: 21 CFR 882.4150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896723 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896723: Clip Gun with Raney Type Scalp Clips, Omni Medical Designs (1990) Summary page 1.

## Recalls of this device
- May 3, 2018 · Class II · Z-3212-2018: 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 bee
- Dec 20, 2017 · Class II · Z-0622-2018: Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

## Indications for use
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.

Source page: https://510kreport.com/device/K050044
Methodology: https://510kreport.com/methodology