510(k) K190032 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Disposable Sclerotherapy Needle
| Applicant | Hangzhou AGS MedTech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Feb 27, 2020 |
| Received | Jan 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190032
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.