# K234131: Resolv Endoscopic Hemostat System

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Jul 26, 2024 after 211 days
- Product code: QAU (Hemostatic Device For Endoscopic Gastrointestinal Use)
- Device class: 2
- Regulation: 21 CFR 878.4456
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K042834 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190677: EndoClot, Endoclot Plus Co., Ltd. (2021) Summary page 4.

## Indications for use
The Hemostasis Resolv Endoscopic Hemostat System is intended for use under the care of a health care professional for hemostasis of upper nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.

Source page: https://510kreport.com/device/K234131
Methodology: https://510kreport.com/methodology