Disposable Hemostatic Clips— 510(k) K232450
Substantially EquivalentZhejiang Soudon Medical Technology Co., Ltd.
FDA 510(k) clearance K232450 for Disposable Hemostatic Clips, Substantially Equivalent on 2024-01-26. Applicant: Zhejiang Soudon Medical Technology Co., Ltd..
Clearance details
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd.
- Product code
- Code PKL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Adverse events under product code PKL
product code PKL- Death
- 9
- Injury
- 489
- Malfunction
- 4,698
- Other
- 1
- Total
- 5,197
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.