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510(k) K102409

DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 by Byrne Medical, Inc. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2010
Date Received
August 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by Byrne Medical, Inc.

  • K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR (June 20, 2012)
  • K113119 — ENDOGATOR ADVANTAGE IRRIGATION PUMP (April 27, 2012)
  • K102855 — UNIVERSAL IRRIGATION SOLUTION HYBRID (November 19, 2010)
  • K102581 — DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 (November 8, 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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  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)