510(k) K250701

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) by Olympus Medical Systems Corp. — Product Code FDT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 5, 2025
Date Received: March 7, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Duodenoscope And Accessories, Flexible/Rigid
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Olympus Medical Systems Corp.

K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315) (February 22, 2026)
K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)
K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single (May 27, 2025)
K250296 — Disposable Distal Attachment D-201 Series (May 1, 2025)
K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)

Other clearances for product code FDT

K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM (March 9, 2026)
K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315) (February 22, 2026)
K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (August 1, 2024)
K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2 (April 16, 2024)
K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (May 11, 2022)
K210710 — PENTAX Medical Video Duedenoscope ED34-i10T2 (April 9, 2021)
K202365 — Pentax Medical Video Duodenoscope ED32-i10 (April 1, 2021)
K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (December 8, 2020)
K203028 — FUJIFILM Distal End Cap (October 30, 2020)