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