510(k) K231249 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Jul 28, 2023 |
| Received | May 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2025 | Pentax of America Inc Pentax Medical Video Processor;
Model Number: EPK-i8020c; Open, Classified |
PEA | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.