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510(k) K202922

END 200 Endoscopic Tubeset by Palliare , Ltd. — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
September 29, 2020
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 Palliare , Ltd.

  • K232902 — EVA15 insufflator (May 2, 2024)
  • K230474 — EVA5 Insufflator (March 24, 2023)
  • K222901 — EVA15 insufflator (January 27, 2023)
  • K202799 — EVA15 (October 21, 2020)
  • K193520 — EVA 15 Insufflator (July 23, 2020)

Other clearances for product code FCX

  • K240847 — MedicCO2LON (MedicCO2LON) (October 30, 2024)
  • K230474 — EVA5 Insufflator (March 24, 2023)
  • 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)