Clearance Summary
Evacore Fully Disposable Vacuum Assist Biopsy Device received FDA 510(k) clearance under submission number K150088, sponsored by Pin-Point Care Corp.. 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 2015-07-20.
- Submission: K150088
- Applicant / Sponsor: Pin-Point Care Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2015-07-20
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.