K233942

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

510(k) number: K233942
Device name: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
Applicant: Pentax of America, Inc. NJ · US
Product code: FDT — Duodenoscope And Accessories, Flexible/Rigid
Decision date: 2024-08-01
Date received: 2023-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain

Also available from FDA: K233942.pdf

Official FDA record: K233942

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.