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The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.

The external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel.

The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.

The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding. The external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel. The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Flexflo Magnetically Guided Enteral Feeding Tube). It outlines the regulatory approval process and the intended use of the device, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence to a predicate device rather than performance metrics from a specific study.

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