FDA 510(k)

SmartSurgN Visualization System

K-Number: K242163 · 2026-04-20

Decision Date2026-04-20

Product CodeOWN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SmartSurgN Visualization System is a medical device manufactured by SmartsurgN, Inc.. It received FDA 510(k) clearance on 2026-04-20 under approval number K242163. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartSurgN Visualization System?

SmartSurgN Visualization System is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by SmartsurgN, Inc.. The 510(k) number is K242163.

When was SmartSurgN Visualization System approved by the FDA?

SmartSurgN Visualization System received FDA 510(k) clearance on 2026-04-20, under approval number K242163.

What company makes SmartSurgN Visualization System?

SmartSurgN Visualization System is manufactured by SmartsurgN, Inc..

What is the FDA product code for SmartSurgN Visualization System?

The FDA product code for SmartSurgN Visualization System is OWN.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT07275723 A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions ACTIVE_NOT_RECRUITING

Other Devices by SmartsurgN, Inc.

K242772AirSurgN Insufflator (10030/AirSurgN)

Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.