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U.S. FDA Medical Device Gastro-Urology Hook 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 Gastro-Urology Hook companies with:

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