# K162197: EndoClot

- Pathway: 510(k) (Traditional)
- Applicant: Endoclot Plus Co., Ltd.
- Decided: Jan 18, 2017 after 166 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042834 (2005). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123325: Medafor Direct Gas-Assisted Application System, Medafor, Inc. (2013) Summary page 4.

## Most influential descendants
- K190677: EndoClot (2021), 1 descendant of its own
- K234131: Resolv Endoscopic Hemostat System (2024), 0 descendants of its own

## Indications for use
The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.

Source page: https://510kreport.com/device/K162197
Methodology: https://510kreport.com/methodology