510(k) K191282
- Device
- PENTAX Medical EPK-i7010 And PENTAX EPK-i5010 Video Processors With GI Family
- Applicant
- PENTAX Of America, Inc.
- 510(k) number
- K191282
- Product code
- PEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-11-08
- Date received
- 2019-05-13
- Regulation
- 876.1500
- Classification name
- Endoscope, Accessories, Image Post-processing For Color Enhancement
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William Goeller
- Address
- 3 Paragon Dr., Montvale NJ US 07645 07645
FDA Registration Numbers#
- 3010703925
- 3003782610
- 3014055212
- 3004638277
- 3042225166
- 3006161756
- 3011416394
- 9610877
- 3014605202
- 3006786907
- 3003775006
Source Documents#
Other 510(k) Records For Product Code PEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | 2025-06-03 |
| 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 |
| 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 |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax of America, Inc. | 2018-07-03 |
| K160275 | Fuse Endoscopic System with FuseBox Processor | Endochoice, Inc. | 2016-08-01 |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015-11-24 |
| K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR | Fujifilm Medical Systems U.S.A, Inc. | 2014-08-22 |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | Pentax Medical | 2013-04-10 |
Legacy Summary#
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FDA Review#
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