Product Code: FDT FDA class 2 21 CFR 876.1500

Duodenoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology

The Duodenoscope and Accessories (Flexible/Rigid) (product code FDT) is an endoscopic instrument used to examine the duodenum and perform various procedures within the duodenum, including endoscopic retrograde cholangiopancreatography (ERCP). It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: FDT
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251861	FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000	Mar 09, 2026	Substantially Equivalent	Fujifilm Corporation
K253646	Single Use Distal Cover MAJ-2315 (MAJ-2315)	Feb 22, 2026	Substantially Equivalent	Olympus Medical Systems Corp.
K251867	EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)	Sep 19, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
K250701	Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)	Jun 05, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
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 )	Aug 01, 2024	Substantially Equivalent	Pentax of America, Inc.
K233886	Ambu® aScope Duodeno 2, Ambu® aBox 2	Apr 16, 2024	Substantially Equivalent	Ambu A/S
K220587	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	May 11, 2022	Substantially Equivalent	Olympus Medical Systems Corp.
K210710	PENTAX Medical Video Duedenoscope ED34-i10T2	Apr 09, 2021	Substantially Equivalent	Pentax of America, Inc.
K202365	Pentax Medical Video Duodenoscope ED32-i10	Apr 01, 2021	Substantially Equivalent	Pentax of America, Inc.
K202661	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	Dec 08, 2020	Substantially Equivalent	Olympus Medical Systems Corp.
K203028	FUJIFILM Distal End Cap	Oct 30, 2020	Substantially Equivalent	Fujifilm Corporation
K201098	Ambu Duodeno System	Jul 17, 2020	Substantially Equivalent	Ambu Innovation GmbH
K193182	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	Jan 17, 2020	Substantially Equivalent	Olympus Medical Systems Corp.
K193202	EXALT Model D Single-Use Duodenoscope, EXALT Controller	Dec 13, 2019	Substantially Equivalent	Boston Scientific Corporation
K192245	Pentax Medical Video Duodenoscope ED34-i10T2	Nov 15, 2019	Substantially Equivalent	Pentax of America, Inc.
K192280	PENTAX Medical ED-3490TK Video Duodenoscope	Oct 21, 2019	Substantially Equivalent	Pentax Medical
K191747	FUJIFILM Duodenoscope Model ED-580XT	Sep 27, 2019	Substantially Equivalent	Fujifilm Corporation
K181745	FUJIFILM Duodenoscope Model	Mar 28, 2019	Substantially Equivalent	Fujifilm Corporation
K182051	FUJIFILM Duodenoscope Model	Oct 02, 2018	Substantially Equivalent	Fujifilm Corporation
K181522	PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope	Jul 09, 2018	Substantially Equivalent	Pentax of America, Inc.
K161222	PENTAX MEDICAL ED-3490TK, Video Duodenoscope	Feb 07, 2018	Substantially Equivalent	Pentax Medical
K163614	PENTAX Medical ED34-i10T, Video Duodenoscope	Sep 20, 2017	Substantially Equivalent	Pentax Medical
K152257	Fujifilm Duodenoscope Model ED-530XT	Jul 21, 2017	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K143153	EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V	Jan 15, 2016	Substantially Equivalent	Olympus Medical Systems Corp.
K110833	CRE BALLOON DILATATION CATHETER	Apr 20, 2011	Substantially Equivalent	Boston Scientific Corporation
K092710	PENTAX ED-3490TK, VIDEO DUODENOSCOPE	Dec 02, 2009	Substantially Equivalent	Pentax Medical Company
K080403	XTJF TYPE Q160VF1	May 20, 2008	Substantially Equivalent	Olympus Medical Systems Corporation
K042076	FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5	Nov 18, 2004	Substantially Equivalent	Fujinon, Inc.
K024033	XTJF-160AF DUODENOVIDEOSCOPE	Dec 20, 2002	Substantially Equivalent	Olympus Optical Co., Ltd.
K980465	OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS	Apr 21, 1998	Substantially Equivalent	Olympus America, Inc.
K962212	KARL STORZ FRIMBERGER VARIOGUIDE	Dec 13, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K963056	ED-3410, VIDEO DUODENOSCOPE	Oct 10, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K961568	ED-344OT	Jul 09, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K942338	OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES	Nov 30, 1994	Substantially Equivalent	Olympus Corp.
K832006	PENTAX FD-34A DUODENOFIBERSCOPE	Aug 01, 1983	Substantially Equivalent	Pentax Precision Instrument Corp.