Cleared Traditional

K872353 - SURGITEK INFUSION STENT SYSTEM*

K872353 is the FDA 510(k) clearance for SURGITEK INFUSION STENT SYSTEM* by Surgitek. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K872353 · Surgitek · Gastroenterology & Urology device
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Sep 1987
Decision
90d
Days
Class 2
Risk

K872353 is an FDA 510(k) clearance for the SURGITEK INFUSION STENT SYSTEM*. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 90 days - within the typical 510(k) review window.

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.

View all Surgitek devices

Submission Details

510(k) Number K872353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1987
Decision Date September 16, 1987
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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.

Regulatory Peers - FAD Stent, Ureteral

All 53
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K872353.
ECHOSIGHT STENT SET
K914280 · Cook Urological, Inc. · Jan 1992
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
BARD DOUBLE PIGTAIL URETERAL STENT
K861478 · C.R. Bard, Inc. · May 1986
URETERAL STENT
K852389 · American Medical Systems, Inc. · Sep 1985
BARD URETERAL STENT
K823487 · C.R. Bard, Inc. · May 1983