Product code FDT
- Device name
- Duodenoscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation | 2026-03-09 |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026-02-22 |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025-09-19 |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025-06-05 |
| 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 ) | Pentax of America, Inc. | 2024-08-01 |
| K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | Ambu A/S | 2024-04-16 |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022-05-11 |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | 2021-04-09 |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | Pentax of America, Inc. | 2021-04-01 |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-12-08 |
| K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020-10-30 |
| K201098 | Ambu Duodeno System | Ambu Innovation GmbH | 2020-07-17 |
| K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-01-17 |
| K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019-12-13 |
| K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | Pentax of America, Inc. | 2019-11-15 |
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | Pentax Medical | 2019-10-21 |
| K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | 2019-09-27 |
| K181745 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2019-03-28 |
| K182051 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2018-10-02 |
| K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax of America, Inc. | 2018-07-09 |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018-02-07 |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax Medical | 2017-09-20 |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017-07-21 |
| K143153 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V | Olympus Medical Systems Corp. | 2016-01-15 |
| K110833 | CRE BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2011-04-20 |
| K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | Pentax Medical Company | 2009-12-02 |
| K080403 | XTJF TYPE Q160VF1 | Olympus Medical Systems Corporation | 2008-05-20 |
| K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 | Fujinon, Inc. | 2004-11-18 |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | Olympus Optical Co., Ltd. | 2002-12-20 |
| K980465 | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS | Olympus America, Inc. | 1998-04-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14961333246233 | PENTAX Medical | HOYA CORPORATION | 2023-07-31 |
| 14961333232991 | PENTAX Medical | HOYA CORPORATION | 2023-07-31 |
| 14961333232960 | PENTAX Medical | HOYA CORPORATION | 2023-07-31 |
| 04953170064012 | LIGHTGUIDE CAP | OLYMPUS MEDICAL SYSTEMS CORP. | 2021-12-20 |
| 04953170063749 | EYEPIECE CAP | OLYMPUS MEDICAL SYSTEMS CORP. | 2021-12-20 |
| 04547410429046 | FUJIFILM | FUJIFILM CORPORATION | 2021-02-04 |
| 08714729995746 | EXALT™ Model D | BOSTON SCIENTIFIC CORPORATION | 2020-06-05 |
| 08714729983514 | EXALT™ Model D | BOSTON SCIENTIFIC CORPORATION | 2019-12-23 |
| 04953170062841 | ULTRASONIC PROBE | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170061837 | ULTRASONIC PROBE | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 08714729339335 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729773566 | SpyGlass Ocular | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339328 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339342 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339359 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339366 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339380 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339410 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339427 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339434 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729764441 | SpyGlass | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729787938 | SpyGlass Ocular | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 04953170071249 | Air/water valve | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170229503 | EVIS EXERA II DUODENOVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170339967 | EVIS EXERA II DUODENOVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170355707 | All-Channnel Irrigator | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170355721 | Balloon2 | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170367311 | EVIS EXERA II DUODENOVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170368509 | ULTRASONIC PROBE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170368523 | ULTRASONIC PROBE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |