Cleared Traditional

K094039 - HYALO GYN

K094039 is an FDA 510(k) clearance for HYALO GYN, manufactured by Fidia Farmaceutici S.P.A.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K094039 · Fidia Farmaceutici S.P.A. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
128d
Days
Class 2
Risk

K094039 is an FDA 510(k) clearance for the HYALO GYN. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Fidia Farmaceutici S.P.A. (Abano Terme, IT). The FDA issued a Cleared decision on May 7, 2010 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - 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 Fidia Farmaceutici S.P.A. devices

FDA 510(k) Submission Details - K094039

510(k) Number K094039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2009
Decision Date May 07, 2010
Days to Decision 128 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 160d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
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.

Regulatory Peers - NUC Lubricant, Personal

All 213
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K094039.
ONE PERSONAL LUBRICANT (SILICONE)
K110690 · One · Mar 2012
ONE PERSONAL LUBRICANT (WATER BASED)
K110691 · One · Feb 2012
AQUA LUBE
K110325 · Mayer Laboratories, Inc. · Dec 2011
GLYCERIN & PARABEN FREE ASTROGLIDE
K072647 · Biofilm, Inc. · Jan 2008
K-Y BRAND WARMING LIQUID
K070545 · Personal Products Co. · Mar 2007
K-Y BRAND INTRIGUE
K062796 · Personal Products Co. · Dec 2006