FDA.reportPublic FDA data

HOYA Corporation PENTAX Lifecare Division

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037826103003782610HOYA Corporation PENTAX Lifecare Division1N2026-01-0130-2 Okada, Aza-Shimomiyano, Tsukidate KURIHARA-SHI Miyagi JP 987-2203

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
104881031382075K963056ED-3410, VIDEO DUODENOSCOPEFDT1996-10-10
104881615715906K962897EG-3400, VIDEO GASTROSCOPEFDS1996-10-04
104882064306753K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)FDF1996-06-24
104881138471909K961564EG-2940, VIDEO GASTROSCOPEFDS1996-07-09
104881966535282K961563EC-384OTL, VIDEO COLONSCOPEFDF1996-06-19
104881511582594K953286FCP-9P, FIBER CHOLEDOCHOSCOPEFBN1995-11-03
104881174420712K951579EC-3800TL, VIDEO COLONOSCOPEFDF1996-03-21
104881694521352K951577ES-3800, VIDEO SIGMOIDOSCOPEFAM1996-03-21
104881997900361K951574EC-3800L, VIDEO COLONOSCOPEFDF1996-03-21
104881272415962K951199FB-18X, FIBER BRONCHOSCOPEEOQ1995-04-10
104881010620828K951198FE-34TH, FIBER ESOPHAGOSCOPEGCL1995-05-30
104881375126373K951196FNL-10P, FIBER NASOPARHYNGOSCOPEEOB1995-04-07
104881038708067K934920VB-1830/VB-1530, VIDEO BRONCHOSCOPEEOQ1994-01-26
104881734210357K934918EPM-3300 VIDEO PROCESSORFET1994-02-07
104881549264138K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2EOB1992-07-01
104881215261651K914106PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10PFGB1992-01-10
104881153279706K914008PENTAX CYSTOFIBERSCOPE, MODEL FCY-15PFAJ1992-01-10
104881475048779K850020PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23FDS1985-07-09
104881872974021K771739PENTAX LH-150F LIGHT SOURCEFCW1977-09-30
104881894616136K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)FDS2025-12-16
104881960014427K251127PENTAX Medical Video Processor (EPK-i8020c)PEA2025-06-03
104881189305078K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF2025-01-03
104881532680760K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)FDS2024-12-06
104881015698327K233942PENTAX 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 )FDT2024-08-01
104881987166977K232249PENTAX Medical Gas/Water Feeding Valve OE-B14ODC2023-12-01
104881418477107K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPEA2023-07-28
104881811550355K223072PENTAX Medical Video Esophagoscope EE17-J10EOX2022-12-02
104881251376121K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10EOB2022-11-16
104881389947832K210928PENTAX Medical Video Bronchoscope EB11-J10EOQ2021-10-21
104881494557354K210177PENTAX Medical Video Upper GI Scopes EG17-J10FDS2021-10-20
104881394689707K202365Pentax Medical Video Duodenoscope ED32-i10FDT2021-04-01
104881699144776K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesEOQ2020-07-30
104881955357140K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)ODG2020-07-23
104881949062388K192245Pentax Medical Video Duodenoscope ED34-i10T2FDT2019-11-15
104881910273385K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPEA2019-11-08
104881768635636K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPEA2019-12-20
104881967294821K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2019-09-06
104881576165984K182004PENTAX Medical Endoscopic Ultrasound SystemODG2018-08-21
104881720303083K180292PENTAX Video Upper G.I. Scope EG34-i10FDS2018-10-12
104881718832838K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesFDF2018-10-26
104881389825331K172156PENTAX Medical EPK-3000 Video Imaging SystemEOB2018-04-05
104882012847989K163614PENTAX Medical ED34-i10T, Video DuodenoscopeFDT2017-09-20
104881063557348K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerODG2017-04-13
104881262411964K162151PENTAX Medical ENT Video Imaging SystemEOB2017-04-20
104881185029424K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopeFDT2018-02-07
104881725645045K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPEA2015-11-24
104881540560731K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSEOQ2014-04-25
104882048340769K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)FDS2014-04-10
104881874947943K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)FDF2014-04-09
104881319240169K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)EOQ2014-04-10
104881541504641K130247PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
104881424250724K130206PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
104881738778854K122470PENTAX EPK-I5010 VIDEO PROCESSORPEA2013-04-10
104881603526158K041397EG-3830UTITX2004-06-09
104881429514428K023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEODG2003-02-11
104881085015168K023376EB-1830T3, VIDEO BRONCHOSCOPEEOQ2002-10-16
104881090456463K010740FG-36UX, FIBER ULTRASOUND GASTROSCOPEODG2001-04-17
104881045843189
104881066023518
104881068216838
104881223892710
104881322663441
104881411900222
104881453612202
104881528568361
104881575075530
104881611113436
104881617185412
104881643540047
104881750668979
104881765927892
104881841106797
104881851201175
104881855329733
104881921814720
104881970219193
104882008124673
104882016744865
104882046468169

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FDS82025-12-16
EOQ82021-10-21
FDF72025-01-03
ODG72020-07-23
PEA62025-06-03
FDT62024-08-01
EOB52022-11-16
ODC12023-12-01
EOX12022-12-02
ITX12004-06-09
FAM11996-03-21
FBN11995-11-03
GCL11995-05-30
FET11994-02-07
FGB11992-01-10
FAJ11992-01-10
FCW11977-09-30