Authors: Sarah Assali, DO, Nova Szoka, MD
Xenocor secured FDA approval for the Xenoscope device in January 2020.
The Xenoscope is a 5mm disposable articulating laparoscopic device intended to be discarded after a single use, thus minimizing costs associated with re-processing and decontamination, decreasing operating room turnover time, and preventing cross-contamination between different patients and cases. Xenoscope produces a 1080p high definition picture and is compatible across multiple display platforms via a compact reusable Xenobox video processor. The scope contains a 0° camera on a 5mm shaft with a 30° articulating tip, allowing for an increased visual range. It also possesses an anti-fog system and illumination light with focus controller.
This device was found to be comparable and substantially equivalent to the predicate device Xenoscope Laparoscope (K161838) and the reference device Xenoscope Laparoscope (K171344).
The Xenoscope is approved for use with the Xenobox video processor for diagnostic and therapeutic use in endoscopic surgery within the thoracic and peritoneal cavities, hollow organs, and female reproductive organs.