Disposable Sphincterotome— 510(k) K232825
Substantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.
FDA 510(k) clearance K232825 for Disposable Sphincterotome, Substantially Equivalent on 2024-03-29. Applicant: Jiangsu Vedkang Medical Science and Technology Co., Ltd..
Clearance details
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.
- Product code
- Code KNS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.