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510(k) K123047

BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET by Bracco Diagnostic, Inc. — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2013
Date Received
September 28, 2012
Clearance Type
Traditional
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

Other clearances by Bracco Diagnostic, Inc.

  • K132192 — BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (February 14, 2014)
  • K111648 — BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR (November 3, 2011)

Other clearances for product code FCX

  • K240847 — MedicCO2LON (MedicCO2LON) (October 30, 2024)
  • K230474 — EVA5 Insufflator (March 24, 2023)
  • K202922 — END 200 Endoscopic Tubeset (July 8, 2021)
  • K201096 — CO2mbiLED (June 23, 2020)
  • K190985 — BAROnova Insufflation System, BAROnova Accessory Kit (May 14, 2019)
  • K180711 — FUJIFILM Endoscopic CO2 Regulator GW-100 (May 25, 2018)
  • K162332 — Nexcore GI Insufflator (September 29, 2016)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132192 — BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (February 14, 2014)
  • K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR (June 20, 2012)