510(k) K191282 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | May 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191282
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.