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U.S. FDA Medical Device Suprapubic Cannula & Trocar Requirements


FDA Medical Device Definition: A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

Registrar Corp assists Suprapubic Cannula & Trocar companies with:

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