Clearance Summary
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices received FDA 510(k) clearance under submission number K201244, sponsored by Transmed7, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-08-07.
- Submission: K201244
- Applicant / Sponsor: Transmed7, LLC
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2020-08-07
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.