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U.S. FDA Medical Device Self-Retaining Retractor 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 Self-Retaining Retractor companies with:

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