Pentax of America, Inc.
FDA 510(k) & PMA Approved Devices — 39 products
Total Devices39
Categories11
Latest Approval2025-12-16
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | FDS | 2025-12-16 | View |
| 510(k) | K251127 | PENTAX Medical Video Processor (EPK-i8020c) | PEA | 2025-06-03 | View |
| 510(k) | K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | FDF | 2025-01-03 | View |
| 510(k) | K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | FDS | 2024-12-06 | View |
| 510(k) | K233942 | PENTAX 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 ) | FDT | 2024-08-01 | View |
| 510(k) | K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | GEH | 2024-07-24 | View |
| 510(k) | K232860 | PENTAX 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-J10U | EOQ | 2024-01-18 | View |
| 510(k) | K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | EOQ | 2024-01-12 | View |
| 510(k) | K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | ODC | 2023-12-01 | View |
| 510(k) | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | PEA | 2023-07-28 | View |
| 510(k) | K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | EOQ | 2022-12-21 | View |
| 510(k) | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | EOX | 2022-12-02 | View |
| 510(k) | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | EOB | 2022-11-16 | View |
| 510(k) | K212814 | C2 CryoBalloon Ablation System | GEH | 2021-11-29 | View |
| 510(k) | K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | EOQ | 2021-10-21 | View |
| 510(k) | K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | FDS | 2021-10-20 | View |
| 510(k) | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | PCV | 2021-10-01 | View |
| 510(k) | K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | FDS | 2021-05-13 | View |
| 510(k) | K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | FDT | 2021-04-09 | View |
| 510(k) | K202365 | Pentax Medical Video Duodenoscope ED32-i10 | FDT | 2021-04-01 | View |
| 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-J10U | ODG | 2020-12-30 | View |
| 510(k) | K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | GEH | 2020-11-24 | View |
| 510(k) | K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | EOQ | 2020-07-30 | 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) | ODG | 2020-07-23 | 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-i10cL | PEA | 2019-12-20 | View |
| 510(k) | K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | FDT | 2019-11-15 | View |
| 510(k) | K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | FDS | 2019-11-12 | View |
| 510(k) | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | PEA | 2019-11-08 | View |
| 510(k) | K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | EOQ | 2019-09-06 | View |
| 510(k) | K183691 | PENTAX Medical ENT Video Imaging System | EOB | 2019-06-12 | View |
| 510(k) | K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | EOQ | 2019-05-23 | View |
| 510(k) | K181084 | PENTAX Video Colonoscopes (EC Family) | FDF | 2019-01-18 | View |
| 510(k) | K182846 | PENTAX Medical EPK-3000 Video Imaging System | EOB | 2019-01-09 | View |
| 510(k) | K182004 | PENTAX Medical Endoscopic Ultrasound System | ODG | 2018-08-21 | View |
| 510(k) | K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | FDT | 2018-07-09 | View |
| 510(k) | K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | PEA | 2018-07-03 | View |
| 510(k) | K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope | EOQ | 2018-01-19 | View |
| 510(k) | K162151 | PENTAX Medical ENT Video Imaging System | EOB | 2017-04-20 | 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 Scanner | ODG | 2017-04-13 | View |
No matching devices.