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510(k) K113310

ENDOGATER AVANTAGE CO2 INSUFFLATOR by Byrne Medical, Inc. — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
November 8, 2011
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 Byrne Medical, Inc.

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  • K102855 — UNIVERSAL IRRIGATION SOLUTION HYBRID (November 19, 2010)
  • K102581 — DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 (November 8, 2010)
  • K102409 — DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 (November 4, 2010)
  • K093665 — ENDO SMARTCAP (December 15, 2009)
  • K092090 — ERBELIFT HAND PUMP AND FLEXIBLE PROBE (November 30, 2009)
  • K092429 — ENDOGATOR (November 19, 2009)
  • K090851 — DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301 (July 2, 2009)
  • K060962 — ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 (April 19, 2006)
  • K033695 — IRRIGATION CHANNEL TUBING, MODEL 100135 (December 23, 2003)

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  • 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)