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FDA 510(k)

Sunny Cup and Applicator

K-Number: K233361 · 2024-06-21

ApplicantMenstrual Mates
Decision Date2024-06-21
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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