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FDA 510(k)

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

Número K: K260007 · 2026-04-01

RequerenteHudi Pharma Srl
Data da decisão2026-04-01
Código do produtoNUC
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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