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510(k) K250268

HyperSnap Surgical System (HSS) by Hypervision Surgical — Product Code SFE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 24, 2025
Date Received: January 30, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Device Class: Class II
Regulation Number: 876.1500
Review Panel: SU
Submission Type

To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.