510(k) K180731 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Ultramatrix EUS Balloon
| Applicant | United States Endoscopy Group, Inc. (Us Endoscopy), Mentor OH, US |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Mar 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180731
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.