Cleared Traditional

K021737 - REPHRESH VAGINAL GEL

K021737 is an FDA 510(k) clearance for REPHRESH VAGINAL GEL, manufactured by Columbia Laboratories, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021737 · Columbia Laboratories, Inc. · Obstetrics & Gynecology device
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Aug 2002
Decision
90d
Days
Class 2
Risk

K021737 is an FDA 510(k) clearance for the REPHRESH VAGINAL GEL. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Columbia Laboratories, Inc. (Rockville Centre, US). The FDA issued a Cleared decision on August 26, 2002 after a review of 90 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.

FDA 510(k) Submission Details - K021737

510(k) Number K021737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date August 26, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 161d · This submission: 90d
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 248
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K021737.
INSTEAD INTIMATE LUBRICANT
K033776 · Instead, Inc. · Jun 2004
K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
K040340 · Personal Products Company, Div. of Mcneil-Ppc, Inc. · Apr 2004
K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
K040164 · Personal Products Company, Div. of Mcneil-Ppc, Inc. · Apr 2004
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
K021492 · Personal Products Co., Div. of Mcneil Ppc, Inc. · Aug 2002
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
K020827 · Personal Products Co., Div. of Mcneil Ppc, Inc. · Jun 2002
TROJAN PASSION BERRY GEL
K013433 · Armkel, LLC · Mar 2002
K021737 · REPHRESH VAGINAL GEL
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