510(k) K200090 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Jul 23, 2020 |
| Received | Jan 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. Open, Classified |
ODG | None listed |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U. Open, Classified |
ODG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.