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