Clearance Summary
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA received FDA 510(k) clearance under submission number K133499, sponsored by Suzhou Beinuo Medical Equipment Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2014-01-14.
- Submission: K133499
- Applicant / Sponsor: Suzhou Beinuo Medical Equipment Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2014-01-14
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.