U.S. FDA Medical Device Wire Holding Forceps 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.
FDA Wire Holding Forceps Establishment Registration
FDA Wire Holding Forceps Listing
FDA Wire Holding Forceps Label Requirements and Exceptions
FDA Wire Holding Forceps Import Information
FDA Wire Holding Forceps Detentions (Wire Holding Forceps Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Wire Holding Forceps Manufacturers (Wire Holding Forceps Suppliers)
- Wire Holding Forceps Distributors
- Wire Holding Forceps Processors
- Wire Holding Forceps Repackers
- Wire Holding Forceps Relabelers
- Wire Holding Forceps Exporters
- Wire Holding Forceps Importers
For more information about Wire Holding Forceps Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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