SFE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
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| Record | Firm | Date |
|---|---|---|
| Instrument Exit Point on Touch Surgery™ Aide (K253984) | Covidien, LLC | 2026-06-04 |
| HyperSnap Surgical System (HSS) (K250268) | Hypervision Surgical | 2025-06-24 |
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Every clearance here is in the API, with alerts when new ones post.