U.S. FDA Medical Device Endoscopic Bite Block Requirements
FDA Medical Device Definition: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
FDA Endoscopic Bite Block Establishment Registration
FDA Endoscopic Bite Block Listing
FDA Endoscopic Bite Block Label Requirements and Exceptions
FDA Endoscopic Bite Block Import Information
FDA Endoscopic Bite Block Detentions (Endoscopic Bite Block Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Endoscopic Bite Block Manufacturers (Endoscopic Bite Block Suppliers)
- Endoscopic Bite Block Distributors
- Endoscopic Bite Block Processors
- Endoscopic Bite Block Repackers
- Endoscopic Bite Block Relabelers
- Endoscopic Bite Block Exporters
- Endoscopic Bite Block Importers
For more information about Endoscopic Bite Block 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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