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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 the device name listed in this FDA 510(k) record. The listed applicant is Hudi Pharma Srl. It received FDA 510(k) clearance on 2026-04-01 under 510(k) 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. The listed applicant is Hudi Pharma Srl. The 510(k) number is K260007.

When did Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) receive FDA 510(k) clearance?

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

Who is the listed applicant for Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)?

The FDA 510(k) record lists Hudi Pharma Srl as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07038070Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer StudyWITHDRAWNNCT07185191Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)RECRUITINGNCT07683468Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With EndometriosisRECRUITINGNCT07701863F-GYN for Vaginal Dryness and Vulvovaginal AtrophyNOT_YET_RECRUITING

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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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