510(k) K011886 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Aug 27, 2001 |
| Received | Jun 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UM160 - 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.