Home / 510(k) Clearances / K153698

510(k) K153698

LumenR Tissue Retractor System by Lumenr, LLC — Product Code ODB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 19, 2016
Date Received: December 23, 2015
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.