FDA 510(k) Applications Submitted by PENTAX OF AMERICA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203024 |
10/02/2020 |
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
PENTAX of America, Inc. |
| K181084 |
04/24/2018 |
PENTAX Video Colonoscopes (EC Family) |
PENTAX of America, Inc. |
| K173554 |
11/17/2017 |
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope |
PENTAX of America, Inc. |
| K173679 |
12/01/2017 |
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes |
PENTAX of America, Inc. |
| K130206 |
01/28/2013 |
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
PENTAX OF AMERICA, INC. |
| K130247 |
02/01/2013 |
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
PENTAX OF AMERICA, INC. |
| K150618 |
03/10/2015 |
PENTAX Medical EPK-i7010 Video Processor with GI Family |
PENTAX OF AMERICA, INC. |
| K162151 |
08/02/2016 |
PENTAX Medical ENT Video Imaging System |
PENTAX OF AMERICA, INC. |
| K162447 |
09/01/2016 |
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 |
PENTAX of America, Inc. |
| K143727 |
12/29/2014 |
PENTAX Medical EKP-i5010 Video Processor with EB Family |
PENTAX OF AMERICA, INC. |
| K113873 |
12/30/2011 |
PENTAX EPK-I5020 VIDEO PROCESSOR |
PENTAX OF AMERICA, INC. |
| K200090 |
01/16/2020 |
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) |
PENTAX of America, Inc. |
| K210177 |
01/22/2021 |
PENTAX Medical Video Upper GI Scopes EG17-J10 |
PENTAX of America, Inc. |
| K220465 |
02/17/2022 |
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 |
PENTAX of America, Inc. |
| K210485 |
02/19/2021 |
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) |
PENTAX of America, Inc. |
| K210710 |
03/10/2021 |
PENTAX Medical Video Duedenoscope ED34-i10T2 |
PENTAX of America, Inc. |
| K200678 |
03/16/2020 |
PENTAX Medical Video Bronchoscope EB-J10 Series |
PENTAX of America, Inc. |
| K190799 |
03/28/2019 |
PENTAX Medical Video Upper GI Scopes (EG Family) |
PENTAX of America, Inc. |
| K190805 |
03/29/2019 |
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 |
PENTAX of America, Inc. |
| K210928 |
03/29/2021 |
PENTAX Medical Video Bronchoscope EB11-J10 |
PENTAX of America, Inc. |
| K231249 |
05/01/2023 |
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL |
PENTAX of America, Inc. |
| K191282 |
05/13/2019 |
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family |
PENTAX of America, Inc. |
| K181522 |
06/11/2018 |
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope |
PENTAX of America, Inc. |
| K212201 |
07/14/2021 |
PENTAX Medical Auto Leakage Tester SHA-P6 |
PENTAX of America, Inc. |
| K182004 |
07/27/2018 |
PENTAX Medical Endoscopic Ultrasound System |
PENTAX of America, Inc. |
| K192245 |
08/19/2019 |
Pentax Medical Video Duodenoscope ED34-i10T2 |
PENTAX of America, Inc. |
| K202365 |
08/19/2020 |
Pentax Medical Video Duodenoscope ED32-i10 |
Pentax of America, Inc. |
| K212814 |
09/03/2021 |
C2 CryoBalloon Ablation System |
PENTAX of America, Inc. |
| K213235 |
09/30/2021 |
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System |
PENTAX of America, Inc. |
| K223072 |
09/30/2022 |
PENTAX Medical Video Esophagoscope EE17-J10 |
PENTAX of America, Inc. |
| K182846 |
10/09/2018 |
PENTAX Medical EPK-3000 Video Imaging System |
PENTAX of America, Inc. |
| K203166 |
10/23/2020 |
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 |
PENTAX of America, Inc. |
| K183516 |
12/18/2018 |
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
PENTAX of America, Inc. |
| K183654 |
12/27/2018 |
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus |
PENTAX of America, Inc. |
| K183691 |
12/31/2018 |
PENTAX Medical ENT Video Imaging System |
PENTAX of America, Inc. |
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