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U.S. FDA Medical Device Rectal Speculum 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 Rectal Speculum companies with:

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