510(k) K222584 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
| Applicant | Olympus Medical Systems Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Apr 26, 2023 |
| Received | Aug 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2024 | Olympus Corporation of the Americas Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 Open, Classified |
FET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.