510(k) K131780 ยท FDF Colonoscope And Accessories, Flexible/Rigid
EVIS EXERA III VIDEO SYSTEM
| Applicant | Olympus Medical Systems Corp., Center Valley PA, US |
| Decision | Substantially Equivalent, Aug 29, 2013 |
| Received | Jun 17, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2024 | Olympus Corporation of the Americas EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for e Open, Classified |
FDF | None listed |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number PCF-H190DL. Open, Classified |
NWB | None listed |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | None listed |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Open, Classified |
FDF | None listed |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Open, Classified |
FDF | None listed |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | None listed |
| Nov 29, 2023 | Aizu Olympus Co., Ltd. PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Open, Classified |
FDF | 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.