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