(97 days)
The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "FARRELL VALVE with CORFLO® ANTI IV Connectors". It does not contain information about acceptance criteria, study details, or device performance metrics typically found in a clinical study report or a summary of safety and effectiveness.
Therefore, I cannot provide the requested information from this document. This letter primarily certifies that the device is substantially equivalent to a predicate device and can be legally marketed, subject to general controls and existing regulations.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.