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