SFE — Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation Class II
FDA product code SFE covers "Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SFE
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.