510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891339Substantially Equivalent

Irri-Flo Irrigation Delivery System

Surgitek, Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891339 is the FDA 510(k) clearance record for IRRI-FLO IRRIGATION DELIVERY SYSTEM, a class II device, cleared for Surgitek 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 29 510(k) clearances for Surgitek, from to . As of , FDA records show no recalls naming K891339.

Clearance record

Decision date
Received
(84 days to decision)
Product code
OCX Endoscopic Irrigation/Suction System
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgitek 3037 Mt. Pleasant St., Racine WI
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