Cleared Traditional

SURX RF SYSTEM (K020952) - FDA 510(k) Clearance

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

K020952 · Surx, Inc. · Gastroenterology & Urology device
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May 2002
Decision
66d
Days
Class 2
Risk

K020952 is an FDA 510(k) clearance for the SURX RF SYSTEM. Classified as Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue (product code MUK), Class II - Special Controls.

Submitted by Surx, Inc. (Livermore, US). The FDA issued a Cleared decision on May 30, 2002 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4400 - 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 Surx, Inc. devices

Submission Details

510(k) Number K020952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date May 30, 2002
Days to Decision 66 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
64d faster than avg
Panel avg: 130d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUK Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition For Shrinkage And Stabilization Of Female Pelvic Tissue For Treatment Of Stress Urinary Incontinence
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.