510(k) K912120 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Aug 7, 1991 |
| Received | May 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Olympus Corporation of the Americas Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891.
This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow bot Open, Classified |
FBN | None listed |
| Dec 12, 2016 | Olympus Corporation of the Americas URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope Terminated |
FBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.