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Woo More Play Coconut Love Oil

by Woo Essentials, Inc.

510(k) K232093

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232093 Date1 Dec 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NUC
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Woo More Play Coconut Love Oil is a personal lubricant device classified under the Obstetrics/Gynecology medical specialty. It is a coconut oil-based lubricant intended for personal use.

The device is supplied as a non-sterile, single-use product and has received FDA 510(k) clearance under K232093. It is regulated as a Class II medical device with product code NUC and regulation number 884.5300.

Other devices from Woo Essentials, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Woo More Play Coconut Love Oil intended for?

    Woo More Play Coconut Love Oil is a personal lubricant device intended for personal use in the Obstetrics/Gynecology medical specialty, formulated as a coconut oil-based lubricant to reduce friction during intimate activities.

  • How is Woo More Play Coconut Love Oil supplied and is it sterile or reusable?

    The device is supplied as a non-sterile, single-use product, meaning it is not sterilized before use and is designed for one-time application only to ensure hygiene and safety.

  • What regulatory clearance does Woo More Play Coconut Love Oil have and under what classification?

    Woo More Play Coconut Love Oil has received FDA 510(k) clearance under submission K232093 and is regulated as a Class II medical device with product code NUC and regulation number 884.5300.