U.S. FDA Medical Device Bladder Evacuator Requirements
FDA Medical Device Definition: A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.
FDA Bladder Evacuator Label Requirements and Exceptions
FDA Bladder Evacuator Import Information
FDA Bladder Evacuator Detentions (Bladder Evacuator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Bladder Evacuator Manufacturers (Bladder Evacuator Suppliers)
- Bladder Evacuator Distributors
- Bladder Evacuator Processors
- Bladder Evacuator Repackers
- Bladder Evacuator Relabelers
- Bladder Evacuator Exporters
- Bladder Evacuator Importers
For more information about Bladder Evacuator Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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