510(k) K051645 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
EVIS EXERA 160A SYSTEM
| Applicant | Olympus Medical Systems Corporation, Melville NY, US |
| Decision | Substantially Equivalent, Oct 13, 2005 |
| Received | Jun 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051645
| 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 |
| 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 |
| Dec 17, 2018 | Olympus Corporation of the Americas Olympus GIF-H180J Gastrointestinal Videoscope - 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.