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Swiss Navy Premium Silicone Lubricant

by Package Solutions, LLC

510(k) K150153

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 NumberK150153 Date20 Oct 2015ClearedStatusActive

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  • Withdrawn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)

Full name
Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
510(k) Number
FDA Product Code
NUC
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Swiss Navy Premium Silicone Lubricant is a personal lubricant device designed to provide long-lasting lubrication with a velvety feel. It is formulated as a non-absorbable silicone-based product intended for personal use.

The device is supplied in various sizes and features a patented 'leak proof' bottle design with a locking pump for single-hand application. It is FDA 510(k) cleared with product code NUC and is manufactured by Package Solutions, LLC in Pompano Beach, FL.

Questions

AI-generated answers, 25 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 Swiss Navy Premium Silicone Lubricant designed for?

    Swiss Navy Premium Silicone Lubricant is a personal lubricant device designed to provide long-lasting lubrication with a velvety feel. It is formulated as a non-absorbable silicone-based product intended for personal use.

  • How is Swiss Navy Premium Silicone Lubricant supplied?

    The device is supplied in various sizes and features a patented 'leak proof' bottle design with a locking pump for single-hand application, making it convenient and easy to use.

  • What is the regulatory status of Swiss Navy Premium Silicone Lubricant?

    Swiss Navy Premium Silicone Lubricant is FDA 510(k) cleared with product code NUC, manufactured by Package Solutions, LLC in Pompano Beach, FL, and was cleared on October 20, 2015.

  • Is Swiss Navy Premium Silicone Lubricant single-use or reusable?

    The device is designed for multiple uses with its leak-proof bottle and locking pump mechanism, allowing for convenient storage and repeated applications as needed.