Clearance Summary
ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE received FDA 510(k) clearance under submission number K934398, sponsored by Transamerican Technologies Intl.. 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 1994-02-14.
- Submission: K934398
- Applicant / Sponsor: Transamerican Technologies Intl.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-02-14
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.