Cleared Traditional

K883173 - MODEL 27084 UROMAT FOR UROLOGICAL IRRIG...

K883173 is the FDA 510(k) clearance for MODEL 27084 UROMAT FOR UROLOGICAL IRRIG... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883173 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Oct 1988
Decision
90d
Days
Class 2
Risk

K883173 is an FDA 510(k) clearance for the MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 90 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K883173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1988
Decision Date October 25, 1988
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 59
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K883173.
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
WASHING CATHETER
K875264 · Endovations · Mar 1988
RAPID ENDOSCOPIC LAVAGE SYSTEM
K862058 · Endovations · Aug 1986
MODEL #27224P CONTINUOUS FLOW PUMP
K832009 · KARL STORZ Endoscopy-America, Inc. · Jul 1983