510(k) K172309 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Endoscopic Ultrasound Aspiration Needle
| Applicant | Micro-Tech (Nanjing) Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Jul 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2018 | Micro-Tech (Nanjing) Co., Ltd. Trident Endoscopic Ultrasonic Biopsy Needle (FNB) Terminated |
ODG | None listed |
| Mar 12, 2018 | Micro-Tech (Nanjing) Co., Ltd. Trident Endoscopic Ultrasonic Aspiration Needle (FNA) Terminated |
ODG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.