G-tubes

Standard Tapered Bougie, 38Fr

by Standard Bariatrics, Inc

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.

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Standard Tapered Bougie, 38Fr models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
STB38— Not statedAvailable

FDA clearances

  • 510(k) K222085 October 2022

Procedures that use g-tubes

Frequently asked questions

What is Standard Tapered Bougie, 38Fr 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 Tapered Bougie, 38Fr?

Standard Tapered Bougie, 38Fr is made by Standard Bariatrics, Inc. It is listed under gastrostomy and gj tubes in our device library.

What sizes does Standard Tapered Bougie, 38Fr come in?

The FDA device database does not list sizes for Standard Tapered Bougie, 38Fr. Check the instructions for use or ask a Standard Bariatrics, Inc representative.

Is Standard Tapered Bougie, 38Fr MRI safe?

The FDA device database entry for Standard Tapered Bougie, 38Fr does not state its MRI safety status. Check the labeling before MRI.

Is Standard Tapered Bougie, 38Fr FDA cleared?

Standard Tapered Bougie, 38Fr 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.

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