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U.S. FDA Medical Device Line Clamp 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 Line Clamp companies with:

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