Cleared Traditional

KY Banksy Moisture

K183505 · Rb Health (Us), LLC · Obstetrics & Gynecology

May 2019

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K183505 is an FDA 510(k) clearance for the KY Banksy Moisture, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on May 17, 2019, 150 days after receiving the submission on December 18, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K183505 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2018
Decision Date	May 17, 2019
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	NUC — Lubricant, Personal
Device Class	Class II — 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.