510(k) K212852 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
| Applicant | Micro-Tech (Nanjing) Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Dec 6, 2021 |
| Received | Sep 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212852
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.