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. Device class: 2.
Clearance details
- Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code KNT
view allMore clearances from Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
view all- K190029 — Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
- K161905 — Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
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.