510(k) K232997 ยท FDS Gastroscope And Accessories, Flexible/Rigid
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
| Applicant | Olympus Medical Systems Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Jun 19, 2024 |
| Received | Sep 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2024 | Olympus Corporation of the Americas EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 Open, Classified |
FDS | None listed |
| Nov 20, 2024 | Olympus Corporation of the Americas Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
Product Name: Olympus GIF-1TH190
Model/Catalog Number: GIF-1TH190
Software Version: N/A
Product Description: This instrument is intend Open, Classified |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.