Cleared Traditional

K902710 - FOLEY CATHETER

K902710 is an FDA 510(k) clearance for FOLEY CATHETER, manufactured by Societa Gruppi Elastomeri S.A.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K902710 · Societa Gruppi Elastomeri S.A. · Gastroenterology & Urology device
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Nov 1990
Decision
154d
Days
Class 2
Risk

K902710 is an FDA 510(k) clearance for the FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Societa Gruppi Elastomeri S.A. (Mendrisio, ES). The FDA issued a Cleared decision on November 21, 1990 after a review of 154 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 Societa Gruppi Elastomeri S.A. devices

FDA 510(k) Submission Details - K902710

510(k) Number K902710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1990
Decision Date November 21, 1990
Days to Decision 154 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K902710.
NORTA
K935630 · Beiersdorf, Inc. · Oct 1994
SILICONE FOLEY CATHETER
K930344 · Cook Urological, Inc. · Apr 1994
WRP FOLEYCATH
K903777 · Wembley Rubber Products (M) Sdn Bhd · Dec 1990
CURITY 100% SILICONE IRRIGATION FOLEY
K810691 · The Kendal Co. · Mar 1981
CATHETER, SILICONE COATED
K772218 · Concord Laboratories, Inc. · Dec 1977