FDA.reportPublic FDA data

510(k) K232518

Device
EndoSound Vision System; EVS
Applicant
Endosound, Inc.
510(k) number
K232518
Product code
ODG
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-27
Date received
2023-08-18
Regulation
876.1500
Classification name
Endoscopic Ultrasound System, Gastroenterology-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Patrick Herriman
Address
4640 S. Macadam Ave. Unit 200 Portland OR US 97239 97239

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation2025-10-03
K251542InstaFANOnepass Medical , Ltd.2025-07-18
K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.2024-03-08
K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation2022-12-30
K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation2022-08-19
K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation2022-08-04
K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation2022-06-03
K212852Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.2021-12-06
K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.2020-12-30
K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)Pentax of America, Inc.2020-07-23
K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation2019-09-05
K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc.2018-08-21
K180731Ultramatrix EUS BalloonUnited States Endoscopy Group, Inc. (Us Endoscopy)2018-04-19
K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.2018-01-11
K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific2017-10-27