FDA 510(k) Applications for Medical Device Product Code "PEA"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K160275 | EndoChoice Inc. | Fuse Endoscopic System with FuseBox Processor | 08/01/2016 |
| K140149 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | EPX-4440HD DIGITAL VIDEO PROCESSOR | 08/22/2014 |
| K122470 | PENTAX MEDICAL | PENTAX EPK-I5010 VIDEO PROCESSOR | 04/10/2013 |
| K191282 | PENTAX of America, Inc. | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | 11/08/2019 |
| K173679 | PENTAX of America, Inc. | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | 07/03/2018 |
| K150618 | PENTAX OF AMERICA, INC. | PENTAX Medical EPK-i7010 Video Processor with GI Family | 11/24/2015 |
| K190805 | PENTAX of America, Inc. | 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 | 12/20/2019 |
| K231249 | PENTAX of America, Inc. | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | 07/28/2023 |
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