510(k) K011314 ยท ITX Transducer, Ultrasonic, Diagnostic
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
| Applicant | Aloka Co., Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, May 15, 2001 |
| Received | Apr 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011314
| 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 |
| May 5, 2022 | Olympus Corporation of the Americas Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging. Open, Classified |
ITX | None listed |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastroint Terminated |
ITX | None listed |
| Oct 16, 2020 | Olympus Corporation of the Americas Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointe Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.