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510(k) K180711

FUJIFILM Endoscopic CO2 Regulator GW-100 by Fujifilm Corporation — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2018
Date Received
March 19, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K123047 — BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (August 6, 2013)
  • K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR (June 20, 2012)