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510(k) K190985

BAROnova Insufflation System, BAROnova Accessory Kit by Baronova, Inc. — Product Code FCX

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 14, 2019
Date Received
April 15, 2019
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 Baronova, Inc.

  • K191078 — BAROnova Access Sheath Kit (July 22, 2019)
  • K172575 — BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap (January 18, 2018)

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)
  • 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)