Clearance Summary
MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN received FDA 510(k) clearance under submission number K091178, sponsored by Mtp Medical Technical Promotion GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-07-31.
- Submission: K091178
- Applicant / Sponsor: Mtp Medical Technical Promotion GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2009-07-31
Classification & Regulation
This clearance is catalogued under FDA product code MMP and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.