Devices · Hypervision Surgical

HyperSnap Surgical System (HSS)

Hypervision Surgical is listed for HyperSnap Surgical System (HSS) (K250268). The FDA list gives June 24, 2025 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SFE as “Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation”: To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250268

Official FDA database record

Date of final decision

June 24, 2025

Company on the FDA list

Hypervision Surgical

Lead panel

Gastroenterology-Urology

Primary product code

SFE

openFDA device name for the code

Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation

Device class

2

Regulation number

876.1500

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary