XNY Disposable Gastric Calibration Tube— 510(k) K250389
Substantially EquivalentChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd
FDA 510(k) clearance K250389 for XNY Disposable Gastric Calibration Tube, Substantially Equivalent on 2025-04-10. Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd.
Clearance details
- Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Product code
- Code KNT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.