Polypectomy Snare— 510(k) K221713
Substantially EquivalentHangzhou AGS MedTech Co., Ltd.
FDA 510(k) clearance K221713 for Polypectomy Snare, Substantially Equivalent on 2023-03-03. Applicant: Hangzhou AGS MedTech Co., Ltd..
Clearance details
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Product code
- Code FDI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Adverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
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.