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U.S. FDA Medical Device Hemostatic Clip Applier Requirements


FDA Medical Device Definition: A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Registrar Corp assists Hemostatic Clip Applier companies with:

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