FDA Product Code
FDA Product Code PEA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | 2025-06-03 | Traditional | PDF ↗ |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | Pentax of America, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| 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 | Pentax of America, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | Pentax of America, Inc. | 2019-11-08 | Traditional | PDF ↗ |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax of America, Inc. | 2018-07-03 | Traditional | PDF ↗ |
| K160275 | Fuse Endoscopic System with FuseBox Processor | Endochoice, Inc. | 2016-08-01 | Traditional | PDF ↗ |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015-11-24 | Traditional | PDF ↗ |
| K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR | Fujifilm Medical Systems U.S.A, Inc. | 2014-08-22 | Traditional | PDF ↗ |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | Pentax Medical | 2013-04-10 | Traditional | PDF ↗ |
Product code PEA · Class II · Gastroenterology, Urology. Data: openFDA.