FDA 510(k)

Sunny Cup and Applicator

Número K: K233361 · 2024-06-21

Data da decisão2024-06-21

Código do produtoHHE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sunny Cup and Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Menstrual Mates. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233361. The device is classified under product code HHE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sunny Cup and Applicator?

Sunny Cup and Applicator is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Menstrual Mates. The 510(k) number is K233361.

When did Sunny Cup and Applicator receive FDA 510(k) clearance?

Sunny Cup and Applicator received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233361.

Who is the listed applicant for Sunny Cup and Applicator?

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

What is the FDA product code for Sunny Cup and Applicator?

The FDA product code for Sunny Cup and Applicator is HHE.

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