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U.S. FDA Medical Device Laparotomy Ring 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 Laparotomy Ring companies with:

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