Panels › Gastroenterology, Urology › Product code PEA · Class 2
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Regulation 876.1500
0510(k)s in 12 months (9 all time)
1recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in PEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Pentax of America, Inc. | 6 | 5 |
| Endochoice, Inc. | 1 | 0 |
| Fujifilm Medical Systems U.S.A, Inc. | 1 | 0 |
| Pentax Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2025 | K251127 | PENTAX Medical Video Processor (EPK-i8020c) Pentax of America, Inc. | PEA |
| Jul 28, 2023 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonosco Pentax of America, Inc. | PEA |
| Dec 20, 2019 | K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonosco Pentax of America, Inc. | PEA |
| Nov 8, 2019 | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family Pentax of America, Inc. | PEA |
| Jul 3, 2018 | K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes Pentax of America, Inc. | PEA |
| Aug 1, 2016 | K160275 | Fuse Endoscopic System with FuseBox Processor Endochoice, Inc. | PEA |
| Nov 24, 2015 | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family Pentax of America, Inc. | PEA |
| Aug 22, 2014 | K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR Fujifilm Medical Systems U.S.A, Inc. | PEA |
| Apr 10, 2013 | K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR Pentax Medical | PEA |
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