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510(k) K151471

Radifocus Glidewire Endoscopic Wire by Terumo Medical Corporation — Product Code OCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2015
Date Received
June 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

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