Cleared Traditional

FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR (K932809) - FDA 510(k) Clearance

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

K932809 · Excalibur Engineering Care of Rms, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
281d
Days
Class 2
Risk

K932809 is an FDA 510(k) clearance for the FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Excalibur Engineering Care of Rms, Inc. (Palm Florida, US). The FDA issued a Cleared decision on March 17, 1994 after a review of 281 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Excalibur Engineering Care of Rms, Inc. devices

Submission Details

510(k) Number K932809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date March 17, 1994
Days to Decision 281 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
151d slower than avg
Panel avg: 130d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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.