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510(k) K102409

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

K102409 is an FDA 510(k) premarket notification submitted by Byrne Medical, Inc. for the device "DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304". The FDA issued a decision of Substantially Equivalent on November 4, 2010. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Byrne Medical, Inc. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code ODC

  • K252933 — DYNE PORT (June 12, 2026)
  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • 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)

FDA data resources