Clearance Summary
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR received FDA 510(k) clearance under submission number K131511, sponsored by Changzhou Sinolinks Medical Innovation 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 2013-07-05.
- Submission: K131511
- Applicant / Sponsor: Changzhou Sinolinks Medical Innovation Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2013-07-05
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.