FDA Medical Device Definition: A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.
FDA Penile Clamp Label Requirements and Exceptions
FDA Penile Clamp Import Information
FDA Penile Clamp Detentions (Penile Clamp Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Penile Clamp Manufacturers (Penile Clamp Suppliers)
- Penile Clamp Distributors
- Penile Clamp Processors
- Penile Clamp Repackers
- Penile Clamp Relabelers
- Penile Clamp Exporters
- Penile Clamp Importers
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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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