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U.S. FDA Medical Device Gastro-Urology Stylet Requirements

FDA Medical Device Definition: A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Registrar Corp assists Gastro-Urology Stylet companies with:

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