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U.S. FDA Medical Device Non-Electrical Snare 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 Snare companies with:

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