# K223916: PUMA-G System

- Pathway: 510(k) (Traditional)
- Applicant: Coaptech, Inc.
- Decided: Mar 29, 2023 after 90 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K852363 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183057: PUMA-G System, Coaptech, LLC (2019) Summary page 4.

## Most influential descendants
- K242211: PUMA-G Pediatric System (2025), 0 descendants of its own

## Indications for use
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size (“Transitional Adolescent B” patients 18 to 21 years of age with no special considerations compared to adults).

Source page: https://510kreport.com/device/K223916
Methodology: https://510kreport.com/methodology