ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)— 510(k) K260521
Substantially EquivalentZhuhai Pusen Medical Technology Co., Ltd.
FDA 510(k) clearance K260521 for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250), Substantially Equivalent on 2026-04-06. Applicant: Zhuhai Pusen Medical Technology Co., Ltd.. Device class: 2.
Summary
Zhuhai Pusen Medical Technology's ClearEVAC Ureteral Aspirating Access Sheath is filed under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). The name lists four model numbers: PUS-100-1040, PUS-100-1050, PUS-100-1240, and PUS-100-1250.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Zhuhai Pusen Medical Technology filed from Zhuhai, China. The decision came 48 calendar days after FDA received it (February 17 to April 6, 2026).
Clearance details
- Applicant
- Zhuhai Pusen Medical Technology Co., Ltd.
- Product code
- Product code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhuhai, CN
Recent devices under product code FED
view allMore clearances from Zhuhai Pusen Medical Technology Co., Ltd.
view all- 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
- K190648 — Pusen Eview Medical Video Endoscope Image Processor
- K172098 — Medical Video Endoscope System
Adverse events under product code FED
product code FED- Death
- 10
- Total
- 10
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.