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U.S. FDA Medical Device Extracorporeal Shock Wave Lithotripter Requirements: Extracorporeal Shock Wave Lithotripter

FDA Medical Device Definition: An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine

Registrar Corp assists Extracorporeal Shock Wave Lithotripter companies with:

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