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U.S. FDA Medical Device Endoscope & Accessories Requirements


FDA Medical Device Definition: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Registrar Corp assists Endoscope & Accessories companies with:

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






 
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.
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