Clearance Summary
Disposable Biopsy Refill Needle received FDA 510(k) clearance under submission number K212819, sponsored by Suzhou Leapmed Healthcare Corporation. 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 2022-07-06.
- Submission: K212819
- Applicant / Sponsor: Suzhou Leapmed Healthcare Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2022-07-06
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.