Clearance Summary
MODIFIED SPACEMAKER SYSTEM received FDA 510(k) clearance under submission number K042412, sponsored by United States Surgical, A Division of Tyco Healthc. 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 2004-09-24.
- Submission: K042412
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2004-09-24
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.