# K040109: Hemorrhage Occluder Pin

- Pathway: 510(k) (Traditional)
- Applicant: Tools For Surgery, LLC
- Decided: Mar 25, 2004 after 65 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890447 (1989). 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)
- K890447: Hemorrhage Occludor, Surgeon Surgical Instrumentation, Inc. (1989) Summary page 1.

## Indications for use
The Hemorrhage Occluder Pin is indicated for the control of localized severe presacral hemorrhage during pelvic surgery, i.e., to occlude internal tissue to stop hemorrhage and aid healing.

Source page: https://510kreport.com/device/K040109
Methodology: https://510kreport.com/methodology