Home / 510(k) Clearances / K080550

510(k) K080550

MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 by Minos Medical — Product Code ODB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 10, 2008
Date Received: February 28, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Endoscopic Contamination Prevention Sheath
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To protect an endoscope from contamination by providing a barrier between the body and the endoscope.