510(k) K051541 ยท FDF Colonoscope And Accessories, Flexible/Rigid
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jul 1, 2005 |
| Received | Jun 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA)
and for endoscopic surgery within the upper digestive tract.
Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5. Open, Classified |
ITX | None listed |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. Terminated |
FDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.