# K123325: Medafor Direct Gas-Assisted Application System

- Pathway: 510(k) (Traditional)
- Applicant: Medafor, Inc.
- Decided: Jan 24, 2013 after 90 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: 1 generation back to K042834 (2005). 1 ancestor in all.
3 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)
- K042834: Micromedics Fibrijet Air Assisted Endoscopic Applicator, Micromedics, Inc. (2005) Summary page 1.

## Most influential descendants
- K162197: EndoClot (2017), 2 descendants of its own
- K190677: EndoClot (2021), 1 descendant of its own
- K234131: Resolv Endoscopic Hemostat System (2024), 0 descendants of its own

## Indications for use
The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.

Source page: https://510kreport.com/device/K123325
Methodology: https://510kreport.com/methodology