510(k) K192793 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jul 17, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number PCF-H190TL. Open, Classified |
NWB | None listed |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number PCF-HQ190L. Open, Classified |
NWB | None listed |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Colonoscope-indicated for use within the lower digestive tract (including the anus,
rectum, sigmoid colon, colon, and ileocecal valve).
Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, Open, Classified |
NWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.