# Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

- Location (FDA's records): Changzhou, CN
- FDA decisions: 3 (2016–2025): 3 510(k) clearances
- Product codes: GCJ (1), GDW (1), KNT (1)
- 510(k) review time since 2016: median 129 days, against 96 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 4 (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
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Changzhou Sinolinks Medical Innovation Co., Ltd.: 1 (https://510kreport.com/company/changzhou-sinolinks-medical-innovation)
- Reach Surgical, Inc.: 1 (https://510kreport.com/company/reach-surgical)
- Reshape Lifesciences: 1 (https://510kreport.com/company/reshape-lifesciences)

## Firms that cite its devices most
- Biotex, Inc.: 1 (https://510kreport.com/company/biotex)
- Sinolinks Medical Innovation, Inc.: 1 (https://510kreport.com/company/sinolinks-medical-innovation)
- M/s. Meril Endo Surgery Private Limited.: 1 (https://510kreport.com/company/m-s-meril-endo-surgery-private)
- Changzhou Ankang Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/changzhou-ankang-medical-instruments)

## Its most-cited devices
- K190029: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar (2019), cited by 4

## Recent decisions
- K250389: XNY Disposable Gastric Calibration Tube (Apr 10, 2025)
- K190029: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar (Sep 26, 2019)
- K161905: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge (Nov 17, 2016)

Source page: https://510kreport.com/company/changzhou-xin-neng-yuan-medical-stapler