Gastroenterology-Urology · 510(k) · 2025
HyperSnap Surgical System (HSS)
Hypervision Surgical. Cleared by FDA on 24 June 2025 under submission K250268, product code SFE (endoscopic video imaging system / software component for real time video augmentation). What FDA's record says, in FDA's words.
Device record · K250268
- Device. HyperSnap Surgical System (HSS)DEVICE
- Company. Hypervision Surgical (GB)COMPANY
- Decision. 24 June 2025, 510(k), substantially equivalent (traditional review); received 30 January 2025DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. SFE, Endoscopic Video Imaging System / Software Component For Real Time Video AugmentationCODE
- Regulation. 21 CFR 876.1500, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedendoscopy
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SFE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SFE, in Gastroenterology-Urology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.