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