# K031882: Endoscopic Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 5, 2003 after 79 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 K913172 (1991). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913172: Endoscopic Delivery System, Medco Products, Co., Inc. (1991) Summary page 2.
- K932466: Medchem Surgical Delivery System, Medco Products, Co., Inc. (1993) Summary page 2.
- K930147: Surgical Mesh Delivery System, General Surgery, Davol, Inc. (1993) Summary page 2.

## Most influential descendants
- K120608: Endoscopic Applicator (2012), 2 descendants of its own
- K123847: Malleable Tip Endoscopic Applicator (2013), 1 descendant of its own
- K193137: EASYGRIP FLO-41 Precision MIS Delivery System (2020), 0 descendants of its own

## Indications for use
This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.

Source page: https://510kreport.com/device/K031882
Methodology: https://510kreport.com/methodology