Cleared Traditional

K833782 - SURGITEK ALL SILICONE INFECTION DOUBJ

K833782 is the FDA 510(k) clearance for SURGITEK ALL SILICONE INFECTION DOUBJ by Surgitek. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K833782 · Surgitek · Gastroenterology & Urology device
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Apr 1984
Decision
157d
Days
Class 2
Risk

K833782 is an FDA 510(k) clearance for the SURGITEK ALL SILICONE INFECTION DOUBJ. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on April 2, 1984 after a review of 157 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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.

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Submission Details

510(k) Number K833782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1983
Decision Date April 02, 1984
Days to Decision 157 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
27d slower than avg
Panel avg: 130d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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.