Cleared Traditional

K931201 - TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER

K931201 is an FDA 510(k) clearance for TRI-MED ENDOSCOPIC FLUID INTRODUCTION C..., manufactured by Tri-Med Specialties, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K931201 · Tri-Med Specialties, Inc. · Gastroenterology & Urology device
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Sep 1993
Decision
203d
Days
Class 2
Risk

K931201 is an FDA 510(k) clearance for the TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on September 28, 1993 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tri-Med Specialties, Inc. devices

FDA 510(k) Submission Details - K931201

510(k) Number K931201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date September 28, 1993
Days to Decision 203 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K931201.
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
K970764 · Comeg Endoscopy · Apr 1997
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · Northgate Technologies, Inc. · Dec 1996
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
K953655 · Johnson & Johnson Medical, Inc. · Oct 1995
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · C.R. Bard, Inc. · Apr 1991
IRRI-FLO IRRIGATION DELIVERY SYSTEM
K891339 · Surgitek · Jun 1989
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
K883173 · KARL STORZ Endoscopy-America, Inc. · Oct 1988