Cleared Special

K171855 - External Moisturizing Gel

K171855 is an FDA 510(k) clearance for External Moisturizing Gel, manufactured by Combe Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Special 510(k) pathway after a 30-day FDA review.

K171855 · Combe Incorporated · Obstetrics & Gynecology device
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Jul 2017
Decision
30d
Days
Class 2
Risk

K171855 is an FDA 510(k) clearance for the External Moisturizing 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 July 21, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Combe Incorporated devices

FDA 510(k) Submission Details - K171855

510(k) Number K171855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2017
Decision Date July 21, 2017
Days to Decision 30 days
Submission Type Special
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
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 212
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K171855.
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
K163674 · Neo Cosmetique · Sep 2017
FuckWater
K171730 · Non-Friction Products, Inc. · Sep 2017
Astroglide O Oil Personal Lubricant & Massage Oil
K171985 · Biofilm, Inc. · Aug 2017
JO Agapé Personal Lubricant
K171021 · United Consortium · Jul 2017
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
K162569 · Biotech Lubricants, Ltd. · Jun 2017
Restore Moisturizing Vaginal Lubricant
K162207 · Good Clean Love · May 2017