Cleared Traditional

K875264 - WASHING CATHETER

K875264 is an FDA 510(k) clearance for WASHING CATHETER, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K875264 · Endovations · Gastroenterology & Urology device
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Mar 1988
Decision
98d
Days
Class 2
Risk

K875264 is an FDA 510(k) clearance for the WASHING CATHETER. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on March 29, 1988 after a review of 98 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 Endovations devices

FDA 510(k) Submission Details - K875264

510(k) Number K875264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date March 29, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 131d · This submission: 98d
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 81
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K875264.
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
RAPID ENDOSCOPIC LAVAGE SYSTEM
K862058 · Endovations · Aug 1986
HOBBS MEDICAL/JAYCO ASPIRATION CATHETER
K844550 · Hobbs Medical, Inc. · Jan 1985
ASPIRATION & IRRIGATION CATHETER
K833331 · Microvasive · Nov 1983