510(k) K024033

XTJF-160AF DUODENOVIDEOSCOPE by Olympus Optical Co., Ltd. — Product Code FDT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 20, 2002
Date Received: December 6, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

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 Optical Co., Ltd.

K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND AN (October 16, 2003)
K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (September 23, 2003)
K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (July 24, 2003)
K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (May 9, 2003)
K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (March 12, 2003)
K021852 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (February 11, 2003)
K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (January 24, 2003)
K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (December 19, 2002)
K013759 — MSS-28CS-301/701 NEEDLESCOPE (August 20, 2002)

Other clearances for product code FDT

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K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (June 5, 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)