FDA 510(k) Applications for Medical Device Product Code "FDT"
(Duodenoscope And Accessories, Flexible/Rigid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K201098 | Ambu Innovation GmbH | Ambu Duodeno System | 07/17/2020 |
| K110833 | Boston Scientific Corporation | CRE BALLOON DILATATION CATHETER | 04/20/2011 |
| K193202 | Boston Scientific Corporation | EXALT Model D Single-Use Duodenoscope, EXALT Controller | 12/13/2019 |
| K203028 | Fujifilm Corporation | FUJIFILM Distal End Cap | 10/30/2020 |
| K181745 | FUJIFILM Corporation | FUJIFILM Duodenoscope Model | 03/28/2019 |
| K182051 | FUJIFILM Corporation | FUJIFILM Duodenoscope Model | 10/02/2018 |
| K191747 | FUJIFILM Corporation | FUJIFILM Duodenoscope Model ED-580XT | 09/27/2019 |
| K152257 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Fujifilm Duodenoscope Model ED-530XT | 07/21/2017 |
| K042076 | FUJINON, INC. | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 | 11/18/2004 |
| K962212 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ FRIMBERGER VARIOGUIDE | 12/13/1996 |
| K980465 | OLYMPUS AMERICA, INC. | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS | 04/21/1998 |
| K143153 | OLYMPUS MEDICAL SYSTEMS CORP. | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V | 01/15/2016 |
| K193182 | Olympus Medical Systems Corp. | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | 01/17/2020 |
| K202661 | Olympus Medical Systems Corp. | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | 12/08/2020 |
| K220587 | Olympus Medical Systems Corp. | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | 05/11/2022 |
| K080403 | OLYMPUS MEDICAL SYSTEMS CORPORATION | XTJF TYPE Q160VF1 | 05/20/2008 |
| K024033 | OLYMPUS OPTICAL CO., LTD. | XTJF-160AF DUODENOVIDEOSCOPE | 12/20/2002 |
| K192280 | Pentax Medical | PENTAX Medical ED-3490TK Video Duodenoscope | 10/21/2019 |
| K161222 | PENTAX MEDICAL | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | 02/07/2018 |
| K163614 | PENTAX Medical | PENTAX Medical ED34-i10T, Video Duodenoscope | 09/20/2017 |
| K092710 | PENTAX MEDICAL COMPANY | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | 12/02/2009 |
| K181522 | PENTAX of America, Inc. | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | 07/09/2018 |
| K210710 | PENTAX of America, Inc. | PENTAX Medical Video Duedenoscope ED34-i10T2 | 04/09/2021 |
| K202365 | Pentax of America, Inc. | Pentax Medical Video Duodenoscope ED32-i10 | 04/01/2021 |
| K192245 | PENTAX of America, Inc. | Pentax Medical Video Duodenoscope ED34-i10T2 | 11/15/2019 |
| K963056 | PENTAX PRECISION INSTRUMENT CORP. | ED-3410, VIDEO DUODENOSCOPE | 10/10/1996 |
| K961568 | PENTAX PRECISION INSTRUMENT CORP. | ED-344OT | 07/09/1996 |
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