510(k) K954451 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
EVIS 140 SYSTEM
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Mar 29, 1996 |
| Received | Sep 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954451
| 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 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other
ancillary equipment for endoscopy and endoscopic surgery
Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V. Open, Classified |
FET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.