Clearance Summary
AUTO-VAC BIOPSY NEEDLE received FDA 510(k) clearance under submission number K912892, sponsored by Angiomed GmbH & Co. Medizintechnik KG. 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 1992-02-07.
- Submission: K912892
- Applicant / Sponsor: Angiomed GmbH & Co. Medizintechnik KG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1992-02-07
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.