U.S. FDA Medical Device Instrument Surgical Tray 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 Instrument Surgical Tray Establishment Registration
FDA Instrument Surgical Tray Listing
FDA Instrument Surgical Tray Label Requirements and Exceptions
FDA Instrument Surgical Tray Import Information
FDA Instrument Surgical Tray Detentions (Instrument Surgical Tray Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Instrument Surgical Tray Manufacturers (Instrument Surgical Tray Suppliers)
- Instrument Surgical Tray Distributors
- Instrument Surgical Tray Processors
- Instrument Surgical Tray Repackers
- Instrument Surgical Tray Relabelers
- Instrument Surgical Tray Exporters
- Instrument Surgical Tray Importers
For more information about Instrument Surgical Tray Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.