Cleared Traditional

ENDOMEDIX Y-ADAPTER (K934170) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934170 · Endomedix · Gastroenterology & Urology device
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Jan 1994
Decision
137d
Days
Class 2
Risk

K934170 is an FDA 510(k) clearance for the ENDOMEDIX Y-ADAPTER. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Endomedix (Irvine, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 137 days - within the typical 510(k) review window.

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 Endomedix devices

Submission Details

510(k) Number K934170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date January 11, 1994
Days to Decision 137 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 130d · This submission: 137d
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 47
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K934170.
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
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