Clearance Summary
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar received FDA 510(k) clearance under submission number K190029, sponsored by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-09-26.
- Submission: K190029
- Applicant / Sponsor: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-09-26
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.