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

- Location (FDA's records): Nanjing, CN
- FDA decisions: 42 (2015–2026): 42 510(k) clearances
- Product codes: PKL (8), FGE (5), JCT (3), KGE (3), ESW (2), ODG (2), FDI (2), GEI (2), KTI (1), FDX (1), FDS (1), FBN (1)
- 510(k) review time since 2016: median 199 days, against 138 for FDA's reviews in the same codes and years (7 of 22 faster)
- Predicates its devices cite: 44 (10 its own); citations of its devices by later devices: 37 (10 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 10 (https://510kreport.com/company/boston-scientific)
- Medi-Globe Corp.: 5 (https://510kreport.com/company/medi-globe)
- Wilson-Cook Medical, Inc.: 3 (https://510kreport.com/company/wilson-cook-medical)
- Olympus America, Inc.: 2 (https://510kreport.com/company/olympus-america)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Olympus Surgical Technologies America: 1 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Mirco-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/mirco-tech-nanjing)
- M.I.Tech Co., Ltd.: 1 (https://510kreport.com/company/mitech)

## Firms that cite its devices most
- Zhejiang Chuangxiang Medical Technology Co., Ltd.: 6 (https://510kreport.com/company/zhejiang-chuangxiang-medical-technology)
- Mirco-Tech (Nanjing) Co., Ltd.: 5 (https://510kreport.com/company/mirco-tech-nanjing)
- Hangzhou AGS MedTech Co., Ltd.: 4 (https://510kreport.com/company/hangzhou-ags-medtech)
- Anrei Medical (Hangzhou) Co., Ltd.: 3 (https://510kreport.com/company/anrei-medical-hangzhou)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-vedkang-medical-science-and-technology)
- Ningbo Xinwell Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/ningbo-xinwell-medical-technology)
- M.I.Tech Co., Ltd.: 1 (https://510kreport.com/company/mitech)

## Its most-cited devices
- K202333: Lockado Repositionable Hemostasis Clip (2021), cited by 5
- K152001: Sterile Repositionable Hemostasis Clipping Device (2015), cited by 4
- K150434: Injection Needle (2015), cited by 4
- K161463: SureClip (TM) Repositionable Hemostasis Clip (2017), cited by 3
- K221784: Single-use Video Pancreaticobiliary Scope, PB Digital Controller (2023), cited by 2
- K180418: Reliant (TM) Multistage Dilatation Balloon Catheter (2018), cited by 2

## Recent decisions
- K261616: Single-Use EBUS Balloon (Oct 15, 2026)
- K252492: Visualized Access and Delivery Catheter; PB Digital Controller (Apr 24, 2026)
- K251692: Advanced Tissue Resection Device (Feb 21, 2026)
- K250229: Dual Action Tissue Closure Device (Sep 8, 2025)
- K243388: Disposable Distal Cap (Jun 27, 2025)
- K243471: Extraction Basket (Dec 16, 2024)
- K230127: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible (Sep 6, 2023)
- K221784: Single-use Video Pancreaticobiliary Scope, PB Digital Controller (Feb 16, 2023)

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