# Mirco-Tech (Nanjing) Co., Ltd.

- Location (FDA's records): Nanjing, CN
- FDA decisions: 5 (2024–2026): 5 510(k) clearances
- Product codes: FBN (2), PKL (1), FBK (1), FGE (1)
- 510(k) review time since 2016: median 130 days, against 175 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Micro-Tech (Nanjing) Co., Ltd.: 5 (https://510kreport.com/company/micro-tech-nanjing)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)

## Its most-cited devices
- K233772: Disposable Dual Action Tissue Closure Device (2024), cited by 1

## Recent decisions
- K260262: Injection Needle (May 29, 2026)
- K253832: Dilation Balloon Catheter (Apr 24, 2026)
- K254153: Single-use Video Scope; PB Digital Controller (Apr 3, 2026)
- K253139: Disposable Distal Cap (Mar 19, 2026)
- K233772: Disposable Dual Action Tissue Closure Device (Mar 19, 2024)

Source page: https://510kreport.com/company/mirco-tech-nanjing