Cleared Traditional

K880660 - SURGITEK SUPER DOUBLE J URETERAL STENT KIT

K880660 is an FDA 510(k) clearance for SURGITEK SUPER DOUBLE J URETERAL STENT KIT, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K880660 · Surgitek · Gastroenterology & Urology device
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Apr 1988
Decision
57d
Days
Class 2
Risk

K880660 is an FDA 510(k) clearance for the SURGITEK SUPER DOUBLE J URETERAL STENT KIT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 57 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

FDA 510(k) Submission Details - K880660

510(k) Number K880660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1988
Decision Date April 14, 1988
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
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 97
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K880660.
VAS-CATH URETERAL STENT CATHETER
K894357 · Vas-Cath, Inc. · Oct 1989
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
PORGES URETERAL STENT
K881744 · Bivona Medical Technologies · May 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · Mentor Corp. · Mar 1988
MENTOR BLACK LIGHT URETERAL STENT SET
K873557 · Mentor Corp. · Feb 1988
SURGITEK INFUSION STENT SYSTEM*
K872353 · Surgitek · Sep 1987