510(k) K251127 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
PENTAX Medical Video Processor (EPK-i8020c)
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Jun 3, 2025 |
| Received | Apr 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251127
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.