U.S. FDA Medical Device Medical Scoop Requirements
FDA Medical Device Definition: A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.
Registrar Corp assists Medical Scoop companies with:
FDA Medical Scoop Establishment Registration
FDA Medical Scoop Listing
FDA Medical Scoop Label Requirements and Exceptions
FDA Medical Scoop Import Information
FDA Medical Scoop Detentions (Medical Scoop Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Medical Scoop Manufacturers (Medical Scoop Suppliers)
- Medical Scoop Distributors
- Medical Scoop Processors
- Medical Scoop Repackers
- Medical Scoop Relabelers
- Medical Scoop Exporters
- Medical Scoop Importers
For more information about Medical Scoop 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.