Clearance Summary
Reach and CQ'ENCE Circular Staplers received FDA 510(k) clearance under submission number K192566, sponsored by Reach Surgical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-10-17.
- Submission: K192566
- Applicant / Sponsor: Reach Surgical, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2019-10-17
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.