510(k) K001241 ยท FDF Colonoscope And Accessories, Flexible/Rigid
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
| Applicant | The Olympus Optical Co., Melville NY, US |
| Decision | Substantially Equivalent, May 9, 2000 |
| Received | Apr 18, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.