Clearance Summary
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING received FDA 510(k) clearance under submission number K895885, sponsored by National-Standard Co.. 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 1990-02-09.
- Submission: K895885
- Applicant / Sponsor: National-Standard Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1990-02-09
Classification & Regulation
This clearance is catalogued under FDA product code FCI and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.