Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EndoSound Vision System; EVS

K-Number: K232518 · 2023-12-27

ApplicantEndosound, Inc.
Decision Date2023-12-27
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoSound Vision System; EVS is a medical device manufactured by Endosound, Inc.. It received FDA 510(k) clearance on 2023-12-27 under approval number K232518. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoSound Vision System; EVS?

EndoSound Vision System; EVS is a medical device that received FDA 510(k) clearance on 2023-12-27. It is manufactured by Endosound, Inc.. The 510(k) number is K232518.

When was EndoSound Vision System; EVS approved by the FDA?

EndoSound Vision System; EVS received FDA 510(k) clearance on 2023-12-27, under approval number K232518.

What company makes EndoSound Vision System; EVS?

EndoSound Vision System; EVS is manufactured by Endosound, Inc..

What is the FDA product code for EndoSound Vision System; EVS?

The FDA product code for EndoSound Vision System; EVS is ODG.

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 NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING NCT06990048 The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System ACTIVE_NOT_RECRUITING NCT06293430 Registry on Luma Vision's VERAFEYE System (ENLIgHT) NOT_YET_RECRUITING NCT07531927 Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy RECRUITING

Other Devices by Endosound, Inc.

K250145Biopsy Port Adapter

Related Devices (Code: ODG)

K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerPentax of America, Inc. K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of 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.

↑