510(k) K210710 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX Medical Video Duedenoscope ED34-i10T2
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 9, 2021 |
| Received | Mar 10, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210710
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2021 | Pentax of America Inc Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.