FDA applicant
Micro-Tech (Nanjing) Co., Ltd.
FDA records 42 decisions for Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN) from 2015 to 2026: 42 510(k) clearances. Most are in product codes PKL (Hemostatic Metal Clip For The Gi Tract) and FGE (Stents, Drains And Dilators For The Biliary…). Since 2016 its 510(k)s took a median of 199 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Micro-Tech (Nanjing) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2018
Class I Class II/III not classified
Planning a device like Micro-Tech (Nanjing) Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report