Cleared Traditional

K964575 - SYMPACATH HYDROGEL COATED FOLEY (FDA 510(k) Clearance)

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

K964575 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
82d
Days
Class 2
Risk

K964575 is an FDA 510(k) clearance for the SYMPACATH HYDROGEL COATED FOLEY. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rusch Intl. devices

Submission Details

510(k) Number K964575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date February 04, 1997
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
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.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 127
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