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510(k) K113119

ENDOGATOR ADVANTAGE IRRIGATION PUMP by Byrne Medical, Inc. — Product Code OCX

K113119 is an FDA 510(k) premarket notification submitted by Byrne Medical, Inc. for the device "ENDOGATOR ADVANTAGE IRRIGATION PUMP". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code OCX (Endoscopic Irrigation/Suction System), 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
April 27, 2012
Date Received
October 21, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other clearances by Byrne Medical, Inc.

  • K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR (June 20, 2012)
  • 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)

Other clearances for product code OCX

  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K233442 — troCarWash™ System (May 21, 2024)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)

FDA data resources