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U.S. FDA Medical Device Esophagoscope (Flexible or Rigid) and Accessories Requirements: Esophagoscope (Flexible or Rigid) and Accessories

FDA Medical Device Definition: An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier

Registrar Corp assists Esophagoscope (Flexible or Rigid) and Accessories companies with:

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




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U.S. FDA Regulations:

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


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