Clearance Summary
ADMS BIOPSY NEEDLE received FDA 510(k) clearance under submission number K890203, sponsored by Advanced Diagnostic Medical Systems, Inc.. 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 1989-03-08.
- Submission: K890203
- Applicant / Sponsor: Advanced Diagnostic Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1989-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.