G-tubes
PUMA-G Pediatric System
A sterile, flexible, tubular device with an inflatable balloon and a magnet at its distal end intended to be placed in the stomach, via the oesophagus, and used to move the stomach to the anterior abdominal wall via attraction by an external magnet (not included), to facilitate a gastrostomy. The balloon is filled with a fluid (e.g., saline) to enable detection by an ultrasound imaging system (not included) for its optimal placement without intervention of other anatomical structures (e.g., organs, vessels). Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire) may be included. This is a single-use device.
Where to buy PUMA-G Pediatric System
We do not have contact details for Coaptech, Inc. yet. Send a request and we will route it to the right person for your country.
PUMA-G Pediatric System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 0010380 | — | Not stated | Available |
| 0010400 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K242211 April 2025
Procedures that use g-tubes
Frequently asked questions
What is PUMA-G Pediatric System used for?
A sterile, flexible, tubular device with an inflatable balloon and a magnet at its distal end intended to be placed in the stomach, via the oesophagus, and used to move the stomach to the anterior abdominal wall via attraction by an external magnet (not included), to facilitate a gastrostomy. The balloon is filled with a fluid (e.g., saline) to enable detection by an ultrasound imaging system (not included) for its optimal placement without intervention of other anatomical structures (e.g., organs, vessels). Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire) may be included. This is a single-use device.
Who makes PUMA-G Pediatric System?
PUMA-G Pediatric System is made by Coaptech, Inc.. It is listed under gastrostomy and gj tubes in our device library.
What sizes does PUMA-G Pediatric System come in?
The FDA device database does not list sizes for PUMA-G Pediatric System. Check the instructions for use or ask a Coaptech, Inc. representative.
Is PUMA-G Pediatric System MRI safe?
The FDA device database entry for PUMA-G Pediatric System does not state its MRI safety status. Check the labeling before MRI.
Is PUMA-G Pediatric System FDA cleared?
PUMA-G Pediatric System is covered by FDA submission K242211.
How do I contact a Coaptech, Inc. sales representative?
Coaptech, Inc. has not listed representatives on LA Vascular yet. Visit the Coaptech, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.