HyperSnap Surgical System (HSS)
FDA 510(k) K250268 · Hypervision Surgical
510(k) numberK250268
Submission
- Device name
- HyperSnap Surgical System (HSS)
- Applicant
- Hypervision Surgical
London, GB - Received
- January 30, 2025
- Decision date
- June 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SFE – Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
Other 510(k)s with product code SFE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253984 | Instrument Exit Point on Touch Surgery AideSFE · Traditional | Covidien, LLC | 06/04/2026SE |
Questions and answers
When was HyperSnap Surgical System (HSS) cleared by the FDA?
HyperSnap Surgical System (HSS) (K250268) received a 510(k) decision of Substantially Equivalent on June 24, 2025, 145 days after the submission was received.
What is the product code of K250268?
The FDA product code is SFE – Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation, a Class II (moderate risk) device regulated under 21 CFR 876.1500.