Search Results

This product must be used only under a doctor's prescription. Its indications for use are medical situations wherein the patient is nourished by an appropriate formula by various means passed into the stomach from the nasal passage. It is used for patients means of a taoo passod into the steman and to masticate or swallow food. The product is not for intravenous feeding.

The Enteral Nutrition device is equivalent to the RPI Enteral Feeding Bag, manufactured by Ridge Products, Inc., carrying 510(k) number K902641. The device is a common enteral feeding bag.

This K970849 submission for the "Enteral Nutrition" device, an enteral feeding bag and accessories, does not contain information about acceptance criteria or a study proving the device meets said criteria.

The submission explicitly states:

• "Clinical data is not needed for most devices cleared by the 510(k) process."
• The device is "identical to units on the market with the exception of our private label" and is "equivalent to the RPI Enteral Feeding Bag, manufactured by Ridge Products, Inc., carrying 510(k) number K902641."

This indicates that the device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device, rather than through new performance studies with acceptance criteria. Therefore, the requested information categories cannot be filled from the provided text.

Ask a specific question about this device