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510(k) K240847

MedicCO2LON (MedicCO2LON) by Ide Vision, Ltd. — Product Code FCX

K240847 is an FDA 510(k) premarket notification submitted by Ide Vision, Ltd. for the device "MedicCO2LON (MedicCO2LON)". The FDA issued a decision of Substantially Equivalent on October 30, 2024. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2024
Date Received
March 27, 2024
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 for product code FCX

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

FDA data resources