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Pentax Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124147603012414760Pentax Medical1N2026-01-016715 Millcreek Drive, Unit 1 Mississauga Ontario CA L5N 5V2
30146052023014605202PENTAX MEDICAL (PENANG) SDN. BHD.1N2026-01-01Plot 554, Lorong Perusahaan 4 Prai Free Trade Zone Penang Pulau Pinang MY 13600

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2745341615715906K962897EG-3400, VIDEO GASTROSCOPEFDS1996-10-04
2745341138471909K961564EG-2940, VIDEO GASTROSCOPEFDS1996-07-09
2745341694521352K951577ES-3800, VIDEO SIGMOIDOSCOPEFAM1996-03-21
2745341272415962K951199FB-18X, FIBER BRONCHOSCOPEEOQ1995-04-10
2745341375126373K951196FNL-10P, FIBER NASOPARHYNGOSCOPEEOB1995-04-07
2745341549264138K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2EOB1992-07-01
2745341894616136K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)FDS2025-12-16
2745341532680760K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)FDS2024-12-06
2745341418477107K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPEA2023-07-28
2745341811550355K223072PENTAX Medical Video Esophagoscope EE17-J10EOX2022-12-02
2745341494557354K210177PENTAX Medical Video Upper GI Scopes EG17-J10FDS2021-10-20
2745341394689707K202365Pentax Medical Video Duodenoscope ED32-i10FDT2021-04-01
2745341699144776K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesEOQ2020-07-30
2745341955357140K200090PENTAX 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
2745341949062388K192245Pentax Medical Video Duodenoscope ED34-i10T2FDT2019-11-15
2745341768635636K190805PENTAX 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
2745341967294821K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2019-09-06
2745341576165984K182004PENTAX Medical Endoscopic Ultrasound SystemODG2018-08-21
2745341720303083K180292PENTAX Video Upper G.I. Scope EG34-i10FDS2018-10-12
2745341718832838K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesFDF2018-10-26
2745341389825331K172156PENTAX Medical EPK-3000 Video Imaging SystemEOB2018-04-05
2745342071264068K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB2018-07-18
2745342012847989K163614PENTAX Medical ED34-i10T, Video DuodenoscopeFDT2017-09-20
2745341063557348K162447PENTAX 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
2745341262411964K162151PENTAX Medical ENT Video Imaging SystemEOB2017-04-20
2745341540560731K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSEOQ2014-04-25
2745342048340769K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)FDS2014-04-10
2745341874947943K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)FDF2014-04-09
2745341319240169K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)EOQ2014-04-10
2745341541504641K130247PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
2745341424250724K130206PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
2745341045843189
2745341322663441
3287801611113436

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FDS72025-12-16
EOQ52020-07-30
ODG52020-07-23
EOB52018-07-18
FDT32021-04-01
PEA22023-07-28
FDF22018-10-26
EOX12022-12-02
FAM11996-03-21

PMN#