Cleared Traditional

K141718 - INTERNAL HYDRATING GEL

K141718 is an FDA 510(k) clearance for INTERNAL HYDRATING GEL, manufactured by Combe Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K141718 · Combe Incorporated · Obstetrics & Gynecology device
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Nov 2014
Decision
141d
Days
Class 2
Risk

K141718 is an FDA 510(k) clearance for the INTERNAL HYDRATING GEL. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Combe Incorporated (White Plains, US). The FDA issued a Cleared decision on November 13, 2014 after a review of 141 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 Combe Incorporated devices

FDA 510(k) Submission Details - K141718

510(k) Number K141718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2014
Decision Date November 13, 2014
Days to Decision 141 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 160d · This submission: 141d
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 K141718.
ID MILLENNIUM, ID MOMENTS SILICONE
K141767 · Westridge Laboratories, Inc. · Mar 2015
Lubrigyn cream
K150147 · Uniderm Farmaceutici Srl · Feb 2015
DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
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DUREX EMBRACE PERSONAL LUBRICANT
K140193 · Reckitt Benckiser, LLC · Nov 2014
ASTROGLIDE SENSUAL STRAWBERRY
K140590 · Biofilm, Inc. · Oct 2014
SIMPLY SLICK PERSONAL LUBRICATING LOTION
K140304 · Simply Solutions, LLC · Oct 2014