G-tubes
Standard Bougie
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 Bougie
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 Bougie 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 |
|---|---|---|---|
| SB18-1 | — | Not stated | Available |
| SB38 | — | Not stated | Available |
FDA clearances
- 510(k) K210437 June 2021
- 510(k) K191885 April 2020
Procedures that use g-tubes
Frequently asked questions
What is Standard Bougie 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 Bougie?
Standard Bougie is made by Standard Bariatrics, Inc. It is listed under gastrostomy and gj tubes in our device library.
What sizes does Standard Bougie come in?
The FDA device database does not list sizes for Standard Bougie. Check the instructions for use or ask a Standard Bariatrics, Inc representative.
Is Standard Bougie MRI safe?
The FDA device database entry for Standard Bougie does not state its MRI safety status. Check the labeling before MRI.
Is Standard Bougie FDA cleared?
Standard Bougie is covered by FDA submissions K191885, K210437.
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.