Pusen Eview Medical Video Endoscope Image Processor— 510(k) K190648
Substantially EquivalentZhuhai Pusen Medical Technology Co., Ltd.
FDA 510(k) clearance K190648 for Pusen Eview Medical Video Endoscope Image Processor, Substantially Equivalent on 2019-03-29. Applicant: Zhuhai Pusen Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhuhai Pusen Medical Technology Co., Ltd.
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tangjiawan Town, CN
Recent devices under product code FET
view allMore clearances from Zhuhai Pusen Medical Technology Co., Ltd.
view all- K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
- K233778 — Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
- K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R +1 more
- K222602 — Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R +1 more
- K172098 — Medical Video Endoscope System
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.