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Pentax of America, Inc.

FDA 510(k) & PMA Approved Devices — 39 products

Total Devices39
Categories11
Latest FDA decision2025-12-16
TypeNumberDevice NameCodeDateActions
510(k) K203166 PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UODG2020-12-30 View
510(k) K203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon CartridgeGEH2020-11-24 View
510(k) K200678 PENTAX Medical Video Bronchoscope EB-J10 SeriesEOQ2020-07-30 View
510(k) K200090 PENTAX 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 View
510(k) K190805 PENTAX 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 View
510(k) K192245 Pentax Medical Video Duodenoscope ED34-i10T2FDT2019-11-15 View
510(k) K190799 PENTAX Medical Video Upper GI Scopes (EG Family)FDS2019-11-12 View
510(k) K191282 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPEA2019-11-08 View
510(k) K183516 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2019-09-06 View
510(k) K183691 PENTAX Medical ENT Video Imaging SystemEOB2019-06-12 View
510(k) K183654 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION PreirusEOQ2019-05-23 View
510(k) K181084 PENTAX Video Colonoscopes (EC Family)FDF2019-01-18 View
510(k) K182846 PENTAX Medical EPK-3000 Video Imaging SystemEOB2019-01-09 View
510(k) K182004 PENTAX Medical Endoscopic Ultrasound SystemODG2018-08-21 View
510(k) K181522 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopeFDT2018-07-09 View
510(k) K173679 PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPEA2018-07-03 View
510(k) K173554 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video BronchoscopeEOQ2018-01-19 View
510(k) K162151 PENTAX Medical ENT Video Imaging SystemEOB2017-04-20 View
510(k) K162447 PENTAX 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 View

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