2 devices · 2 companies · 2025 to 2026
Product code SFE: Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
2 devices under product code SFE, 2025 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation. 21 CFR 876.1500, Class II. To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Instrument Exit Point on Touch Surgery AideK253984 · 510(k) | Covidien, LLC | Gastroenterology-Urology | database entry | |
| HyperSnap Surgical SystemK250268 · 510(k) | Hypervision Surgical | Gastroenterology-Urology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.