510(k) K182004 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
PENTAX Medical Endoscopic Ultrasound System
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Aug 21, 2018 |
| Received | Jul 27, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK. Open, Classified |
ODG | None listed |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. Open, Classified |
ODG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.