Cleared Traditional

K913928 - SURGITEK 4.5FR LUBRI-FLEX(TM) URETERAL ...

K913928 is an FDA 510(k) clearance for SURGITEK 4.5FR LUBRI-FLEX(TM) URETERAL ..., manufactured by Surgitek Medical Engineering Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K913928 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
77d
Days
Class 2
Risk

K913928 is an FDA 510(k) clearance for the SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 77 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 Medical Engineering Corp. devices

FDA 510(k) Submission Details - K913928

510(k) Number K913928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date November 19, 1991
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

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 94
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K913928.
URETERAL STENT
K930733 · Surgitek · Jul 1993
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993
ECHOSIGHT STENT SET
K914280 · Cook Urological, Inc. · Jan 1992
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · Mentor Corp. · Sep 1991
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · Vas-Cath, Inc. · Apr 1991