FDA.report

510(k) K250145

Device
Biopsy Port Adapter
Applicant
Endosound, Inc.
510(k) number
K250145
Product code
ODC
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-17
Date received
2025-01-21
Regulation
876.1500
Classification name
Endoscope Channel Accessory
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code ODC

510(k)DeviceApplicantDecision date
K252910Orca Air/Water and Suction ValvesBoston Scientific2025-10-09
K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation2025-07-16
K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2025-06-20
K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation2025-03-19
K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation2025-02-20
K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)STERIS Corporation2024-11-08
K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation2024-10-11
K241285Disposable Endoscope Valves Set (AF series)Alton (Shanghai) Medical Instruments Co., Ltd.2024-10-01
K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use ConnectorMedivators (A Subsidiary of Steris Corporation)2024-03-22
K232327EndorailEndostart S.R.L.2024-03-15
K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation2024-03-06
K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use ConnectorMedivators (A Subsidiary of Steris Corporation)2024-03-06
K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation2024-02-09
K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterMedivators (A Subsidiary of Steris Corporation)2023-12-21
K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.2023-12-01