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FDA 510(k)

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

K-Number: K260007 · 2026-04-01

ApplicantHudi Pharma Srl
Decision Date2026-04-01
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) is a medical device manufactured by Hudi Pharma Srl. It received FDA 510(k) clearance on 2026-04-01 under approval number K260007. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)?

Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Hudi Pharma Srl. The 510(k) number is K260007.

When was Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) approved by the FDA?

Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) received FDA 510(k) clearance on 2026-04-01, under approval number K260007.

What company makes Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)?

Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) is manufactured by Hudi Pharma Srl.

What is the FDA product code for Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)?

The FDA product code for Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) is NUC.

Related Clinical Trials

NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07038070 Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study WITHDRAWN

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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