Clearance Summary
MTP LAPAROMAT DISPOSABLE TUBING SET received FDA 510(k) clearance under submission number K011360, sponsored by Mtp Medical Technical Promotion GmbH. 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 2001-07-19.
- Submission: K011360
- Applicant / Sponsor: Mtp Medical Technical Promotion GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2001-07-19
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.