510(k) K010591 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
| Applicant | Olympus Optical Co., Ltd., Tokyo, JP |
| Decision | Substantially Equivalent, Mar 15, 2001 |
| Received | Feb 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body. Terminated |
ODG | None listed |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body. Terminated |
ODG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.