Clearance Summary
Disposable Hemostatic Clips received FDA 510(k) clearance under submission number K232969, sponsored by Ningbo Xinwell Medical Technology 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 2024-06-07.
- Submission: K232969
- Applicant / Sponsor: Ningbo Xinwell Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2024-06-07
Classification & Regulation
This clearance is catalogued under FDA product code PKL and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.