510(k) K093507 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
OLYMPUS CHF TYPE Y0003
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Mar 10, 2010 |
| Received | Nov 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs
Model Numb Open, Classified |
FBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.