# K242211: PUMA-G Pediatric System

- Pathway: 510(k) (Traditional)
- Applicant: Coaptech, Inc.
- Decided: Apr 29, 2025 after 274 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: 5 generations back to K852363 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223916: PUMA-G System, Coaptech, Inc. (2023) Summary page 5.

## Indications for use
The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.

Source page: https://510kreport.com/device/K242211
Methodology: https://510kreport.com/methodology