510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113119Substantially Equivalent

Endogator Advantage Irrigation Pump

Byrne Medical, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113119 is the FDA 510(k) clearance record for ENDOGATOR ADVANTAGE IRRIGATION PUMP, a class II device, cleared for Byrne Medical, Inc. on under FDA product code OCX (Endoscopic Irrigation/Suction System). FDA's definition for product code OCX reads: "To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures". FDA records list 12 510(k) clearances for Byrne Medical, Inc., from to . As of , FDA records show no recalls naming K113119.

Clearance record

Decision date
Received
(189 days to decision)
Product code
OCX Endoscopic Irrigation/Suction System
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Byrne Medical, Inc. 14605 28th Ave. N., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCX

Trailing 12 months

FDA records hold no clearances under product code OCX in the trailing twelve months.

FDA records show no clearances under product code OCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260