Cleared Traditional

K981489 - UROSURGE SPIRASTENT PLUS URETERAL STENT

K981489 is an FDA 510(k) clearance for UROSURGE SPIRASTENT PLUS URETERAL STENT, manufactured by Urosurge, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K981489 · Urosurge, Inc. · Gastroenterology & Urology device
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May 1998
Decision
32d
Days
Class 2
Risk

K981489 is an FDA 510(k) clearance for the UROSURGE SPIRASTENT PLUS URETERAL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Urosurge, Inc. (Princeton, US). The FDA issued a Cleared decision on May 29, 1998 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 Urosurge, Inc. devices

FDA 510(k) Submission Details - K981489

510(k) Number K981489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1998
Decision Date May 29, 1998
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.

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 K981489.
DD URETERAL STENT, INTEGRAL STENT
K982974 · Rusch Intl. · Jul 1999
C-FLEX URETERAL STENTS
K991219 · Applied Medical Resources · Jun 1999
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
K983498 · C.R. Bard, Inc. · Dec 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · Boston Scientific Corp · Feb 1998
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc. · Jul 1996
LESE STENTS SETS
K952513 · Cook Urological, Inc. · Jun 1996