Cleared Traditional

NOVASYS TRANSURETHRAL RF SYSTEM (K042132) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042132 · Novasys Medical, Inc. · General & Plastic Surgery device
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Dec 2004
Decision
134d
Days
Class 2
Risk

K042132 is an FDA 510(k) clearance for the NOVASYS TRANSURETHRAL RF SYSTEM. Classified as Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women (product code NVJ), Class II - Special Controls.

Submitted by Novasys Medical, Inc. (Newark, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K042132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date December 21, 2004
Days to Decision 134 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Delivery Of Radio Frequency Energy To The Submucosal Tissue Of The Bladder Neck And Proximal Urethra For The Transurethral Treatment Of Female Stress Urinary Incontinence Due To Hypermobility.
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 General & Plastic Surgery devices follow this clearance model.