# K250268: HyperSnap Surgical System (HSS)

- Pathway: 510(k) (Traditional)
- Applicant: Hypervision Surgical
- Decided: Jun 24, 2025 after 145 days
- Product code: SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931154 (1993). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0, Fujifilm Corporaton (2021) Summary page 5.

## Most influential descendants
- K253984: Instrument Exit Point on Touch Surgery™ Aide (2026), 0 descendants of its own

## Indications for use
The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed. The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view. The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes). The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K250268
Methodology: https://510kreport.com/methodology