Cleared Traditional

K981489 - UROSURGE SPIRASTENT PLUS URETERAL STENT (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 121
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