G-tubes
Standard Precision Bougie Device
A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.
Where to buy Standard Precision Bougie Device
We do not have contact details for Standard Bariatrics, Inc yet. Send a request and we will route it to the right person for your country.
Standard Precision Bougie Device 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 |
|---|---|---|---|
| STB38 | — | Not stated | Available |
FDA clearances
- 510(k) K222085 October 2022
Procedures that use g-tubes
Frequently asked questions
What is Standard Precision Bougie Device used for?
A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.
Who makes Standard Precision Bougie Device?
Standard Precision Bougie Device is made by Standard Bariatrics, Inc. It is listed under gastrostomy and gj tubes in our device library.
What sizes does Standard Precision Bougie Device come in?
The FDA device database does not list sizes for Standard Precision Bougie Device. Check the instructions for use or ask a Standard Bariatrics, Inc representative.
Is Standard Precision Bougie Device MRI safe?
The FDA device database entry for Standard Precision Bougie Device does not state its MRI safety status. Check the labeling before MRI.
Is Standard Precision Bougie Device FDA cleared?
Standard Precision Bougie Device is covered by FDA submission K222085.
How do I contact a Standard Bariatrics, Inc sales representative?
Standard Bariatrics, Inc has not listed representatives on LA Vascular yet. Visit the Standard Bariatrics, 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.