510(k) K013066 ยท MND Ligator, Esophageal
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Dec 11, 2001 |
| Received | Sep 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013066
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2023 | Olympus Corporation of the Americas Single Use Rotatable Clip Fixing Device
Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip
Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip
Mode Open, Classified |
MND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.