Clearance Summary
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE received FDA 510(k) clearance under submission number K083840, sponsored by Msi Medserv International Deutschland 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 2009-09-28.
- Submission: K083840
- Applicant / Sponsor: Msi Medserv International Deutschland GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-09-28
Classification & Regulation
This clearance is catalogued under FDA product code GCM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.