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U.S. FDA Medical Device Amputation Knife 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 Amputation Knife companies with:

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