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

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