Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Gastrointestinal Tube and Accessories Regulations

U.S. FDA Medical Device Gastrointestinal Tube and Accessories Requirements: Gastrointestinal Tube and Accessories

FDA Medical Device Definition: 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)

Registrar Corp assists Gastrointestinal Tube and Accessories companies with:

  • FDA Gastrointestinal Tube and Accessories Establishment Registration
  • FDA Gastrointestinal Tube and Accessories Listing
  • FDA Gastrointestinal Tube and Accessories Label Requirements and Exceptions
  • FDA Gastrointestinal Tube and Accessories Import Information
  • FDA Gastrointestinal Tube and Accessories Detentions (Gastrointestinal Tube and Accessories Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Gastrointestinal Tube and Accessories Manufacturers (Gastrointestinal Tube and Accessories Suppliers)
       - Gastrointestinal Tube and Accessories Distributors
       - Gastrointestinal Tube and Accessories Processors
       - Gastrointestinal Tube and Accessories Repackers
       - Gastrointestinal Tube and Accessories Relabelers
       - Gastrointestinal Tube and Accessories Exporters
       - Gastrointestinal Tube and Accessories Importers
For more information about Gastrointestinal Tube and Accessories Medical Devices, simply click below:




Live Help

 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco