# Zhuhai Pusen Medical Technology Co., Ltd.

- Location (FDA's records): Zhuhai, CN
- FDA decisions: 7 (2017–2026): 7 510(k) clearances
- Product codes: FGB (3), FET (1), FBN (1), FAJ (1), FED (1)
- 510(k) review time since 2016: median 48 days, against 170 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 17 (1 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
- KARL STORZ Endoscopy-America, Inc.: 3 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Shanghai SeeGen Photoelectric Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-seegen-photoelectric-technology)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- Shenzhen Trious Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-trious-medical-technology)

## Firms that cite its devices most
- MacroLux Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/macrolux-medical-technology)
- Hunan Vathin Medical Instrument Co., Ltd.: 3 (https://510kreport.com/company/hunan-vathin-medical-instrument)
- Anhui Happiness Workshop Instruments Co., Ltd.: 1 (https://510kreport.com/company/anhui-happiness-workshop-instruments)
- Zhejiang Geyi Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-geyi-medical-instrument)
- Shenzhen Besdata Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-besdata-technology)
- Contra Healthcare Solutions, LLC: 1 (https://510kreport.com/company/contra-healthcare-solutions)
- Scivita Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/scivita-medical-technology)
- Seplou (Zhuhai) Co., Ltd.: 1 (https://510kreport.com/company/seplou-zhuhai)

## Its most-cited devices
- K172098: Medical Video Endoscope System (2017), cited by 13
- K190648: Pusen Eview Medical Video Endoscope Image Processor (2019), cited by 1
- K222602: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (2022), cited by 1
- K171076: Medical Video Endoscope System (2017), cited by 1
- K233778: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (2024), cited by 1

## Recent decisions
- K260521: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (Apr 6, 2026)
- K233778: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (Jul 16, 2024)
- K223741: Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) (Jun 22, 2023)
- K222602: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (Sep 26, 2022)
- K190648: Pusen Eview Medical Video Endoscope Image Processor (Mar 29, 2019)
- K172098: Medical Video Endoscope System (Aug 31, 2017)
- K171076: Medical Video Endoscope System (May 5, 2017)

Source page: https://510kreport.com/company/zhuhai-pusen-medical-technology