510(k) K100584 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
EVIS EXERAII 180 SYSTEM
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Jul 2, 2010 |
| Received | Mar 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number CF-H180AL. Open, Classified |
NWB | None listed |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number CF-Q180AL. Open, Classified |
NWB | None listed |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number PCF-H180AL. Open, Classified |
NWB | None listed |
| Feb 29, 2024 | Olympus Corporation of the Americas Colonoscope, Model Number PCF-Q180AL. Open, Classified |
NWB | None listed |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
Model Numbers: CF-2T160I, CF-2T160L, CF-H170 Open, Classified |
FET | None listed |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170 Open, Classified |
FDF | None listed |
| Feb 13, 2023 | Olympus Corporation of the Americas EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve)
Model/Serial: CF-Q180AL Open, Classified |
NWB | None listed |
| Apr 22, 2022 | Olympus Corporation of the Americas Colonovideoscope
Model CF-H180AL Terminated |
FDF | None listed |
| Dec 17, 2018 | Olympus Corporation of the Americas Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. Terminated |
NWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.