Skip to content

Coconu Water Based Personal Lubricant

by Coconu, LLC

510(k) K210814

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 NumberK210814 Date14 Jun 2021ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Coconu Water-Based Personal Lubricant is a Lubricant, Personal (NUC classification) designed to provide hydration and reduce friction during intimate sexual activity. It is formulated to supplement natural lubrication, enhancing comfort and ease for penile and vaginal use.

This product is supplied as a single-use, non-sterile, water-based formulation intended for external application. It has received FDA 510(k) clearance under the Obstetrics/Gynecology advisory committee and is classified as Class II. No MRI safety or reusable specifications are noted in the regulatory data.

Questions

AI-generated answers, 19 Sep 2026

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

  • Is this lubricant intended for internal medical use, or is it strictly for external application during intimate activity?

    The Coconu Water-Based Personal Lubricant is explicitly designed for external application only during intimate sexual activity. Its description specifies it is intended to supplement natural lubrication for penile and vaginal use, but it is not meant for internal insertion or medical procedures.

  • How is the Coconu Water-Based Personal Lubricant supplied, and is it single-use or reusable?

    The product is supplied as a single-use item, meaning each application requires a new unit. It is not intended for reuse, as this could compromise hygiene and effectiveness. The packaging is designed for one-time use per application.

  • Is this lubricant sterile, and if not, what precautions should be taken during use?

    The Coconu Water-Based Personal Lubricant is non-sterile, as explicitly stated in the regulatory data. Since it is for external use only, standard hygiene practices—such as washing hands before and after use—should be followed to minimize risk. Sterility is not required for this classification of personal lubricant.

  • What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?

    The Coconu Water-Based Personal Lubricant received FDA clearance through a Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device. The submission was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee, reflecting its classification under Obstetrics/Gynecology (NUC product code).

  • Does this lubricant have any specific storage requirements, or can it be stored at room temperature?

    The provided data does not specify storage conditions beyond its classification as a non-sterile, single-use product. Generally, water-based lubricants like this are stable at room temperature, but users should follow the manufacturer’s instructions (if available) for optimal shelf life and safety. Avoid exposure to extreme temperatures or direct sunlight.