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U.S. FDA Medical Device Manual Surgical Instrument 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 Manual Surgical Instrument companies with:

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