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U.S. FDA Medical Device Non-Electrical Clamp Requirements

FDA Medical Device Definition: A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

Registrar Corp assists Non-Electrical Clamp companies with:

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