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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Water bottle assembly. Model Number. OS-H5. Open, Classified |
PEA | K191282 |
| Aug 15, 2025 | Pentax of America Inc Pentax Medical Video Processor;
Model Number: EPK-i8020c; Open, Classified |
PEA | K231249 K251127 |
| Feb 26, 2025 | Pentax of America Inc Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation.
Model: EPK-i8020c Open, Classified |
PEA | K231249 |
| Feb 26, 2025 | Pentax of America Inc PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EG29-i20c Open, Classified |
PEA | K231249 |
| Feb 26, 2025 | Pentax of America Inc PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EC38-i20cL Open, Classified |
PEA | K231249 |
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