Cleared Traditional

K091516 - WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR (FDA 510(k) Clearance)

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

K091516 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Oct 2009
Decision
147d
Days
Class 2
Risk

K091516 is an FDA 510(k) clearance for the WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Appollo Beach, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 147 days - within the typical 510(k) review window.

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 Well Lead Medical Co., Ltd. devices

Submission Details

510(k) Number K091516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date October 16, 2009
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
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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