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