K250268 is an FDA 510(k) clearance for the HyperSnap Surgical System (HSS). This device is classified as a Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation (Class II - Special Controls, product code SFE).
Submitted by Hypervision Surgical (London, GB). The FDA issued a Cleared decision on June 24, 2025, 145 days after receiving the submission on January 30, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Allow For Visualization Of Body Cavities Through An Endoscope With Real Time Augmentation Of Video Images Via Software To A Monitor..
| 510(k) Number | K250268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2025 |
| Decision Date | June 24, 2025 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | SFE - Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Allow For Visualization Of Body Cavities Through An Endoscope With Real Time Augmentation Of Video Images Via Software To A Monitor. |