510(k) K201121 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Sphincterotome
| Applicant | Hangzhou AGS MedTech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | Apr 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201121
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.