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Panels › Gastroenterology, Urology › Product code FDT · Class 2

Duodenoscope And Accessories, Flexible/Rigid

Regulation 876.1500

2510(k)s in 12 months (35 all time)
8recalls in 12 months (38 all time)
37recalls that name a 510(k)
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Top companies in FDT

Company510(k)sRecalls
Boston Scientific Corporation213
Fujifilm Medical Systems U.S.A, Inc.110
Olympus Corporation of the Americas09
Olympus Medical Systems Corp.80
Pentax of America, Inc.53
Pentax Medical42
Fujifilm Corporation50
Pentax Precision Instrument Corp.30
Olympus America, Inc.11
Ambu A/S10
Decided510(k)Device and applicantCode
Mar 9, 2026K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
Fujifilm Corporation, JP
FDT
Feb 22, 2026K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)
Olympus Medical Systems Corp., JP
FDT
Sep 19, 2025K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
Olympus Medical Systems Corp., JP
FDT
Jun 5, 2025K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
Olympus Medical Systems Corp., JP
FDT
Aug 1, 2024K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use,
Pentax of America, Inc.
FDT
Apr 16, 2024K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
Ambu A/S, DK
FDT
May 11, 2022K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp., JP
FDT
Apr 9, 2021K210710PENTAX Medical Video Duedenoscope ED34-i10T2
Pentax of America, Inc.
FDT
Apr 1, 2021K202365Pentax Medical Video Duodenoscope ED32-i10
Pentax of America, Inc.
FDT
Dec 8, 2020K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp., JP
FDT
Oct 30, 2020K203028FUJIFILM Distal End Cap
Fujifilm Corporation, JP
FDT
Jul 17, 2020K201098Ambu Duodeno System
Ambu Innovation GmbH, DE
FDT
Jan 17, 2020K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp., JP
FDT
Dec 13, 2019K193202EXALT Model D Single-Use Duodenoscope, EXALT Controller
Boston Scientific Corporation
FDT
Nov 15, 2019K192245Pentax Medical Video Duodenoscope ED34-i10T2
Pentax of America, Inc.
FDT
Oct 21, 2019K192280PENTAX Medical ED-3490TK Video Duodenoscope
Pentax Medical
FDT
Sep 27, 2019K191747FUJIFILM Duodenoscope Model ED-580XT
Fujifilm Corporation, JP
FDT
Mar 28, 2019K181745FUJIFILM Duodenoscope Model
Fujifilm Corporation, JP
FDT
Oct 2, 2018K182051FUJIFILM Duodenoscope Model
Fujifilm Corporation, JP
FDT
Jul 9, 2018K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
Pentax of America, Inc.
FDT
Feb 7, 2018K161222PENTAX MEDICAL ED-3490TK, Video Duodenoscope
Pentax Medical
FDT
Sep 20, 2017K163614PENTAX Medical ED34-i10T, Video Duodenoscope
Pentax Medical
FDT
Jul 21, 2017K152257Fujifilm Duodenoscope Model ED-530XT
Fujifilm Medical Systems U.S.A, Inc.
FDT
Jan 15, 2016K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Olympus Medical Systems Corp., JP
FDT
Apr 20, 2011K110833CRE BALLOON DILATATION CATHETER
Boston Scientific Corporation
FDT
Dec 2, 2009K092710PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Pentax Medical Company
FDT
May 20, 2008K080403XTJF TYPE Q160VF1
Olympus Medical Systems Corporation
FDT
Nov 18, 2004K042076FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
Fujinon, Inc.
FDT
Dec 20, 2002K024033XTJF-160AF DUODENOVIDEOSCOPE
Olympus Optical Co., Ltd.
FDT
Apr 21, 1998K980465OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
Olympus America, Inc.
FDT
Dec 13, 1996K962212KARL STORZ FRIMBERGER VARIOGUIDE
KARL STORZ Endoscopy-America, Inc.
FDT
Oct 10, 1996K963056ED-3410, VIDEO DUODENOSCOPE
Pentax Precision Instrument Corp.
FDT
Jul 9, 1996K961568ED-344OT
Pentax Precision Instrument Corp.
FDT
Nov 30, 1994K942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
Olympus Corp.
FDT
Aug 1, 1983K832006PENTAX FD-34A DUODENOFIBERSCOPE
Pentax Precision Instrument Corp.
FDT

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