510(k) K950729 ยท ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
| Applicant | Olympus America, Inc., Lake Success NY, US |
| Decision | Substantially Equivalent, Mar 17, 1995 |
| Received | Feb 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Aomori Olympus Co., Ltd. PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.