Cleared Traditional

ENHANCE CLITORAL STIMULATION AID (K043480) - FDA 510(k) Clearance

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

K043480 · Gynavations, Inc. · Obstetrics & Gynecology device
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Jun 2005
Decision
174d
Days
Class 2
Risk

K043480 is an FDA 510(k) clearance for the ENHANCE CLITORAL STIMULATION AID. Classified as Device, Engorgement, Clitoral (product code NBV), Class II - Special Controls.

Submitted by Gynavations, Inc. (Malden, US). The FDA issued a Cleared decision on June 8, 2005 after a review of 174 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5970 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gynavations, Inc. devices

Submission Details

510(k) Number K043480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date June 08, 2005
Days to Decision 174 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 160d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBV Device, Engorgement, Clitoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5970
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 Obstetrics & Gynecology devices follow this clearance model.