Clearance Summary
MODIFICATION TO AUTO-BAND LIGATOR received FDA 510(k) clearance under submission number K083556, sponsored by Scandimed International. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-02-19.
- Submission: K083556
- Applicant / Sponsor: Scandimed International
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2009-02-19
Classification & Regulation
This clearance is catalogued under FDA product code MND and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.