510(k) K250389
K250389 is an FDA 510(k) premarket notification submitted by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd for the device "XNY Disposable Gastric Calibration Tube". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2025
- Date Received
- February 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type