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Data / Medical devices / Japan / FUJIFILM Corporation Medical Systems Research & Development Center Kaisei

FUJIFILM Corporation Medical Systems Research & Development Center Kaisei: FDA-registered device maker in Ashigarakami-Gun Kanagawa, Japan, 64 510(k) clearances

FUJIFILM Corporation Medical Systems Research & Development Center Kaisei is registered with the FDA (registration 3042225166) in Ashigarakami-Gun Kanagawa, Japan. It lists 30 device types. The FDA files 64 510(k) clearances under its listings, the newest dated June 16, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch FUJIFILM Corporation Medical Systems Research & Development Center Kaisei
FDA registration number
3042225166
Address
577, Ushijima, Kaisei-Machi, Ashigarakami-Gun Kanagawa, Japan, 258-8577
Owner or operator
FUJIFILM CORPORATION (8031568)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
October 2, 2008
Registered through
2026
Brand names listed
AW-500 A-W BUTTON FOR G-5 SCOPES, AW-601 Air/Water Button for Ultrasonic Endoscope, AW-602 Air/Water Valve, AW-603 Air/Water Valve, B20BU Balloon for EB-530US, B20UR Balloon for EG-530UR Series Ultrasonic Endoscopes, B20UT Balloon for EG-530UT Series Ultrasonic Endoscopes, BA-03 Balloon Attachment Tool and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Specification developeraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Specification developeraccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Specification developeraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Bulb, Inflation, For EndoscopeFCY1Specification developeraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Duodenoscope And Accessories, Flexible/RigidFDT2Manufacturer, Specification developeraccessdata.fda.gov
Endoscope, Accessories, Image Post-Processing For Color EnhancementPEA2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Complaint file establishment, Specification developeraccessdata.fda.gov
Endoscopic Bite BlockMNK1Specification developeraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Specification developeraccessdata.fda.gov
Endoscopic Light-Projecting Measuring DeviceQTH2Manufactureraccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Specification developeraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Enteroscope And AccessoriesFDA2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Complaint file establishment, Specification developeraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Complaint file establishment, Specification developeraccessdata.fda.gov
Gastrointesinal Lesion Software Detection SystemQNP2Specification developeraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For EndoscopeFCX2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Specification developeraccessdata.fda.gov
Led Light SourceNTN2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Oximeter, Tissue SaturationMUD2Contract manufactureraccessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/RigidFAM2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufacturer, Specification developeraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 16, 2026K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
March 9, 2026K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000FDTSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 17, 2026K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 6, 2026K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
December 12, 2025K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
June 13, 2025K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000EOQSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
June 10, 2025K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 23, 2025K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFDFSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 11, 2025K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFETSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 1, 2024K243091Over-tube (TR-1108A)FEDSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
October 11, 2024K242779Hood (DH-083ST)FDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 4, 2024K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
June 13, 2024K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFDASubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
February 7, 2024K240075FUJIFILM Endoscope Model EB-710XTEOQSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
December 15, 2023K230751EW10-EC02 Endoscopy Support ProgramQNPSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
December 13, 2023K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITXSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
September 15, 2023K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FEDSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
September 8, 2023K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDFSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 1, 2023K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FDSSubstantially EquivalentFUJIFILM Healthcare Americas Corporationaccessdata.fda.gov
January 27, 2023K221551FUJIFILM Endoscope Model EI-740D/SFDSSubstantially EquivalentFujifilm Corporatonaccessdata.fda.gov
January 11, 2023K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDASubstantially EquivalentFujifilm Corporatonaccessdata.fda.gov
November 10, 2022K220957FUJIFILM Endoscope Model EB-710PEOQSubstantially EquivalentFujifilm Corporatonaccessdata.fda.gov
August 19, 2022K221238FUJIFILM Ultrasonic Endoscope EG-740UTODGSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 4, 2022K221952Endoscope Model EG-580UT and Endoscope Model EG-580URODGSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
June 3, 2022K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODGSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 4, 2022K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGESubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
December 2, 2021K212950FUJIFILM Video Laparoscope EL-R740M30GCJSubstantially EquivalentFujifilm Corporatonaccessdata.fda.gov
October 29, 2021K213195Balloon BS-3FDASubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 19, 2021K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2FDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 9, 2021K210162Endoscope Model EI-740D/SFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
October 30, 2020K203028FUJIFILM Distal End CapFDTSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 20, 2020K202130FUJIFILM Video LaparoscopeGCJSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
July 6, 2020K200850Fujifilm Ultrasonic ProcessorFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 20, 2020K192918Video Laparoscope, Video Processor, Light SourceGCJSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
December 11, 2019K193123FUJIFILM Distal Cap Models 33-40FDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
November 20, 2019K192664FUJIFILM Endoscope Model EC-760Z-V/LFDFSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
September 27, 2019K191747FUJIFILM Duodenoscope Model ED-580XTFDTSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
August 23, 2019K183607FUJIFILM BronchoscopeEOQSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
July 16, 2019K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
June 24, 2019K183032FUJIFILM Double Balloon Endoscope EI580BTFDASubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 7, 2019K190649FUJIFILM Endoscope Model EC-760S-V/LFDFSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 4, 2019K182253FUJIFILM Video BronchoscopesEOQSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
April 2, 2019K182836FUJIFILM Endoscope Model EG-740NFDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
March 28, 2019K181745FUJIFILM Duodenoscope ModelFDTSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 27, 2019K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDASubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
February 22, 2019K182825FUJIFILM Ultrasonic EndoscopeEOQSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
May 25, 2018K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCXSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
March 1, 2018K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDSSubstantially EquivalentFujifilm Corporationaccessdata.fda.gov
January 19, 2018K171291FUJIFILM Bronchoscope Model EB-530PEOQSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
June 15, 2017K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFDSSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
May 9, 2017K171096Fujifilm Diathermic Slitter (FlushKnife)KGESubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
June 29, 2016K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)KGESubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
March 3, 2016K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1FDSSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
February 18, 2016K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)KGESubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
December 15, 2015K153483Balloon controller PB-30FDFSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
August 20, 2015K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFDASubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
September 9, 2014K133976FUJIFILM ENDOSCOPIC CO2 REGULATORFCXSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
January 10, 2014K132210FUJIFILM 600 SERIES ENDOSCOPESFDFSubstantially EquivalentFujifilm Medical Systems U.S.A, Inc.accessdata.fda.gov
December 13, 2012K122535FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530HEOQSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
August 13, 2012K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2FDSSubstantially EquivalentFujinon, Inc.accessdata.fda.gov
July 26, 2012K112391FUJINON COLONOSCOPESFDFSubstantially EquivalentFujinon, Inc.accessdata.fda.gov
June 4, 2012K121035FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530USEOQSubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
August 7, 2009K091773FUJINON STERILE OVERTUBESFEDSubstantially EquivalentFujinon, Inc.accessdata.fda.gov
June 7, 2004K040048FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEMFDASubstantially EquivalentFujinon, Inc.accessdata.fda.gov

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Updated June 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.