510(k) K980465 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Apr 21, 1998 |
| Received | Feb 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon).
Model Number: PCF-S. Open, Classified |
NWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.