Medical Video Endoscope System— 510(k) K172098

Clearance details

Applicant

Zhuhai Pusen Medical Technology Co., Ltd.

Product code

Code FGB

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2017-07-11

Decision date

2017-08-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zhuhai, CN

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• K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
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• 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 more2023-06-22
• K222602 — Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R +1 more2022-09-26
• K190648 — Pusen Eview Medical Video Endoscope Image Processor2019-03-29

Death

6

Injury

552

Malfunction

3,922

Other

1

Total

4,481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →