(397 days)
Intended to be a reusable instrument to provide the physician with a means for direct viewing of the nasal cavity by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.
Ecleris Sinuscope
This document is a 510(k) premarket notification letter from the FDA for the Ecleris Sinuscope. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document does not contain the information requested in points 1-9.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.