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Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

by Hudi Pharma Srl

510(k) K260007

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 NumberK260007 Date1 Apr 2026ClearedStatusActive

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  • Withdrawn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
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, 6 Oct 2026

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

The device is a personal lubricant designed for vaginal application to moisturize and lubricate, enhancing comfort and ease during intimate sexual activity and supplementing the body's natural lubrication. It is a hyaluronic acid vaginal suppository available in two strengths: 5 mg and 10 mg of hyaluronic acid per suppository.

The device is supplied as a vaginal suppository for use in intimate settings. It is not compatible with condoms. The product has received FDA 510(k) clearance under regulation number 884.5300 and product code NUC, classified as a Class II device.

Other devices from Hudi Pharma Srl

Questions

AI-generated answers, 6 Oct 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 the Hyaluronic Acid Vaginal Suppository used for?

    The device is a personal lubricant designed for vaginal application to moisturize and lubricate, enhancing comfort and ease during intimate sexual activity by supplementing the body's natural lubrication. It is formulated with hyaluronic acid to provide sustained moisture and reduce friction.

  • How is the Hyaluronic Acid Vaginal Suppository supplied and what strengths are available?

    The suppository is supplied as a vaginal dosage form for direct application. It is available in two strengths: 5 mg and 10 mg of hyaluronic acid per suppository, allowing users to select the appropriate dose based on individual needs for moisture and lubrication.

  • Is the Hyaluronic Acid Vaginal Suppository compatible with condoms?

    No, the device is not compatible with condoms. The formulation may degrade latex or other condom materials, potentially compromising their integrity and effectiveness as a barrier method during sexual activity.

  • What regulatory pathway was used for the Hyaluronic Acid Vaginal Suppository?

    The product received FDA 510(k) clearance under regulation number 884.5300 and product code NUC, classified as a Class II device. This indicates it was found substantially equivalent to a legally marketed predicate device through a traditional 510(k) submission.