FDA 510(k) Applications Submitted by William Goeller
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K231970 |
07/03/2023 |
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 |
PENTAX of America, Inc. |
| K212201 |
07/14/2021 |
PENTAX Medical Auto Leakage Tester SHA-P6 |
PENTAX of America, Inc. |
| K172156 |
07/18/2017 |
PENTAX Medical EPK-3000 Video Imaging System |
Pentax Medical |
| K182004 |
07/27/2018 |
PENTAX Medical Endoscopic Ultrasound System |
PENTAX of America, Inc. |
| K232249 |
07/28/2023 |
PENTAX Medical Gas/Water Feeding Valve OE-B14 |
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. |
| K192280 |
08/22/2019 |
PENTAX Medical ED-3490TK Video Duodenoscope |
Pentax Medical |
| K212814 |
09/03/2021 |
C2 CryoBalloon Ablation System |
PENTAX of America, Inc. |
| K232860 |
09/15/2023 |
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 |
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. |
| K003229 |
10/10/2000 |
BIOPATCH ANTIMICROBIAL DRESSING |
INTEGRA LIFESCIENCES CORP. |
| 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. |
| K965236 |
12/31/1996 |
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) |
DATASCOPE CORP. |
| K183691 |
12/31/2018 |
PENTAX Medical ENT Video Imaging System |
PENTAX of America, Inc. |
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