HyperSnap Surgical System (HSS) is an AI-enabled medical device from Hypervision Surgical, listed by FDA (510(k), K250268) with a decision date of 2025-06-24. Review panel: Gastroenterology-Urology.
| FDA submission number | K250268 |
|---|---|
| Pathway | 510(k) |
| Company | Hypervision Surgical |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2025-06-24 |
| Decision | Substantially Equivalent |
| Product code | SFE |
| Classification | Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation |
| Device class | 2 |
| Regulation number | 876.1500 |
| Review time (calendar days) | 145 |
| Applicant country | GB |
Official FDA database record · FDA AI-enabled device list
All Gastroenterology-Urology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.