FDA.reportPublic FDA data

Paresh Patel

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96108773008185830Paresh Patel1N2026-01-013 Paragon Drive Montvale NJ US 07645
30335889523033588952Paresh Patel1N2026-01-013 Paragon Dr Montvale NJ US 07645

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
104901031382075K963056ED-3410, VIDEO DUODENOSCOPEFDT1996-10-10
104901615715906K962897EG-3400, VIDEO GASTROSCOPEFDS1996-10-04
104902064306753K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)FDF1996-06-24
104901138471909K961564EG-2940, VIDEO GASTROSCOPEFDS1996-07-09
104901966535282K961563EC-384OTL, VIDEO COLONSCOPEFDF1996-06-19
104901511582594K953286FCP-9P, FIBER CHOLEDOCHOSCOPEFBN1995-11-03
104901174420712K951579EC-3800TL, VIDEO COLONOSCOPEFDF1996-03-21
104901694521352K951577ES-3800, VIDEO SIGMOIDOSCOPEFAM1996-03-21
104901997900361K951574EC-3800L, VIDEO COLONOSCOPEFDF1996-03-21
104901272415962K951199FB-18X, FIBER BRONCHOSCOPEEOQ1995-04-10
104901010620828K951198FE-34TH, FIBER ESOPHAGOSCOPEGCL1995-05-30
104901375126373K951196FNL-10P, FIBER NASOPARHYNGOSCOPEEOB1995-04-07
104901038708067K934920VB-1830/VB-1530, VIDEO BRONCHOSCOPEEOQ1994-01-26
104901734210357K934918EPM-3300 VIDEO PROCESSORFET1994-02-07
104901549264138K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2EOB1992-07-01
104901215261651K914106PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10PFGB1992-01-10
104901153279706K914008PENTAX CYSTOFIBERSCOPE, MODEL FCY-15PFAJ1992-01-10
104901475048779K850020PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23FDS1985-07-09
104901872974021K771739PENTAX LH-150F LIGHT SOURCEFCW1977-09-30
104901894616136K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)FDS2025-12-16
104901960014427K251127PENTAX Medical Video Processor (EPK-i8020c)PEA2025-06-03
104901189305078K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF2025-01-03
104901532680760K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)FDS2024-12-06
104901015698327K233942PENTAX 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
104901945479295K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2024-01-18
104901987166977K232249PENTAX Medical Gas/Water Feeding Valve OE-B14ODC2023-12-01
104901418477107K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPEA2023-07-28
104901811550355K223072PENTAX Medical Video Esophagoscope EE17-J10EOX2022-12-02
104901251376121K220465PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10EOB2022-11-16
104901389947832K210928PENTAX Medical Video Bronchoscope EB11-J10EOQ2021-10-21
104901494557354K210177PENTAX Medical Video Upper GI Scopes EG17-J10FDS2021-10-20
104901394689707K202365Pentax Medical Video Duodenoscope ED32-i10FDT2021-04-01
104901699144776K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesEOQ2020-07-30
104901955357140K200090PENTAX 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
104901949062388K192245Pentax Medical Video Duodenoscope ED34-i10T2FDT2019-11-15
104901910273385K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPEA2019-11-08
104901768635636K190805PENTAX 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
104901967294821K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2019-09-06
104901576165984K182004PENTAX Medical Endoscopic Ultrasound SystemODG2018-08-21
104901720303083K180292PENTAX Video Upper G.I. Scope EG34-i10FDS2018-10-12
104901718832838K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesFDF2018-10-26
104901389825331K172156PENTAX Medical EPK-3000 Video Imaging SystemEOB2018-04-05
104902071264068K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB2018-07-18
3331632071264068K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB2018-07-18
104902012847989K163614PENTAX Medical ED34-i10T, Video DuodenoscopeFDT2017-09-20
104901063557348K162447PENTAX 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
104901262411964K162151PENTAX Medical ENT Video Imaging SystemEOB2017-04-20
104901185029424K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopeFDT2018-02-07
104901725645045K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPEA2015-11-24
104901540560731K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSEOQ2014-04-25
104902048340769K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)FDS2014-04-10
104901874947943K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)FDF2014-04-09
104901319240169K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)EOQ2014-04-10
104901541504641K130247PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
104901424250724K130206PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
104901738778854K122470PENTAX EPK-I5010 VIDEO PROCESSORPEA2013-04-10
104901603526158K041397EG-3830UTITX2004-06-09
104901429514428K023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEODG2003-02-11
104901085015168K023376EB-1830T3, VIDEO BRONCHOSCOPEEOQ2002-10-16
104901090456463K010740FG-36UX, FIBER ULTRASOUND GASTROSCOPEODG2001-04-17
104901045843189
104901066023518
104901068216838
104901223892710
104901322663441
104901411900222
104901453612202
104901528568361
104901575075530
104901611113436
104901617185412
104901643540047
104901674760272
104901750668979
104901765927892
104901841106797
104901851201175
104901855329733
104901921814720
104901970219193
104902008124673
104902016744865
104902046468169

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOQ92024-01-18
FDS82025-12-16
EOB82022-11-16
FDF72025-01-03
ODG72020-07-23
PEA62025-06-03
FDT62024-08-01
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