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510(k) K160846

AmplifEYE by Medivators, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2016
Date Received
March 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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