Cleared Traditional

K941952 - SURGITEK INFUSER

K941952 is the FDA 510(k) clearance for SURGITEK INFUSER by Surgitek. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K941952 · Surgitek · Gastroenterology & Urology device
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May 1994
Decision
32d
Days
Class 2
Risk

K941952 is an FDA 510(k) clearance for the SURGITEK INFUSER. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on May 24, 1994 after a review of 32 days - a notably fast clearance 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: 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 Surgitek devices

Submission Details

510(k) Number K941952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date May 24, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
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 K941952.
LESE STENTS SETS
K952513 · Cook Urological, Inc. · Jun 1996
AQ HYDROPHILIC STENT
K961446 · Cook Urological, Inc. · May 1996
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994
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