Clearance Summary
VICKERS MEDICAL MODEL 112 TREONIC DC2 received FDA 510(k) clearance under submission number K791645, sponsored by Vickers America Medical 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 1979-10-02.
- Submission: K791645
- Applicant / Sponsor: Vickers America Medical Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1979-10-02
Classification & Regulation
This clearance is catalogued under FDA product code FKW and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.