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