Cleared Traditional

K891339 - IRRI-FLO IRRIGATION DELIVERY SYSTEM

K891339 is the FDA 510(k) clearance for IRRI-FLO IRRIGATION DELIVERY SYSTEM by Surgitek. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K891339 · Surgitek · Gastroenterology & Urology device
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Jun 1989
Decision
84d
Days
Class 2
Risk

K891339 is an FDA 510(k) clearance for the IRRI-FLO IRRIGATION DELIVERY SYSTEM. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgitek devices

Submission Details

510(k) Number K891339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date June 02, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 51
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K891339.
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
K092461 · United States Endoscopy Group, Inc. · Nov 2009
ENDOMAT LC PUMP, MODEL 20 3303 20
K031457 · KARL STORZ Endoscopy-America, Inc. · Apr 2004
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · C.R. Bard, Inc. · Apr 1991
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
K883173 · KARL STORZ Endoscopy-America, Inc. · Oct 1988
MODEL #27224P CONTINUOUS FLOW PUMP
K832009 · KARL STORZ Endoscopy-America, Inc. · Jul 1983