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510(k) K183171

ScopeSeal Duodenoscope Protective Device by Gi Scientific, LLC — Product Code ODB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 8, 2019
Date Received: November 16, 2018
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.