SFE — Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation Class II
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250268 | hypervision surgical | HyperSnap Surgical System (HSS) | June 24, 2025 |