Device Information
The ViSiGi 3D Gastric Sizing Tube is designed for single-patient use during gastric and bariatric surgery. It features a closed, rounded tip and is available in three sizes: 32 French, 36 French, and 40 French. An integral suction regulator and vented On/Off slide valve are included. An optional squeeze bulb with a pressure gauge can be connected to the tube for added functionality, such as pressure monitoring.
Indications
ViSiGi 3D is used during gastric and bariatric surgery to aid in stomach decompression, fluid drainage, suction application, leak testing, and as a sizing guide for surgical procedures.
Intended Use
This device is intended for use in surgery centers or hospitals for gastric and bariatric procedures. It helps decompress the stomach, drain fluids, and test for leaks. Surgeons use it as a sizing guide during surgeries.
Availability
Prescription only.
Study Results
- Nonclinical and safety testing: Tests were conducted to ensure bulb compatibility and functionality. The testing demonstrated that the addition of the leak-testing function did not affect the device’s performance or safety.
Regulatory Information
- Regulation Number: 21 CFR 876.5980
- Regulatory Class: Class II
- Product Code: KNT
- 510(k) Number: K234145
- The device must follow regulations for gastrointestinal tubes and accessories under 21 CFR 876.5980. It is subject to general controls like labeling, good manufacturing practices, and registration.
Manufacturer Information
- Name: Boehringer Laboratories
- Address: 300 Thoms Drive, Phoenixville, Pennsylvania 19460
- Contact Person: Nathan Simasek
Predicate Device Information
- Primary Predicate: ViSiGi 3D (K130483)
- Reference Device: Endolumik Fluorescence Guided Gastric Calibration Tube (K222880)
- The difference between the predicate and current device is the addition of a leak-testing function.
References
- ViSiGi 3D Gastric Sizing Tube. 510(k) Number: K234145. Boehringer Laboratories: FDA summary link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K234145
- http://www.boehringerlabs.com
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