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