← Back to catalogue

Feeding Tube

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222773

by Anhui Tiankang Medical Technology Co., Ltd.

Identifiers

510(k) Number
K222773 FDA 510(k)
FDA Product Code
PIF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Gastrointestinal Tube with Enteral Specific Connectors, designed for enteral nutrition delivery. It facilitates the administration of liquids, nutrients, or medications directly into the stomach or small intestine when oral feeding is not feasible, such as in patients with swallowing disorders, gastrointestinal obstructions, or those requiring prolonged nutritional support.

The Feeding Tube is supplied in various sizes and reference codes (e.g., 3010017366, 3005580113) and is classified as a Class II medical device under FDA regulations. It is intended for single-use and must be handled under sterile conditions. The device has received FDA 510(k) clearance as substantially equivalent to predicate devices, with advisory committee review in Gastroenterology and Urology. Storage and handling instructions are specified in the accompanying documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Custom Medical Feeding Tube,OEM Medical Feeding Tube Manufacturers ..., Tiankang Medical | Consumable Medical Supplies,Surgical Consumable ..., 安徽天康医疗科技股份有限公司

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Anhui Tiankang Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K222773 24 fields · synced Sep 19, 2026