Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MOONCUP, STYLE A & B

K-Number: K040335 · 2005-03-30

ApplicantMooncup, LLC
Decision Date2005-03-30
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MOONCUP, STYLE A & B is the device name listed in this FDA 510(k) record. The listed applicant is Mooncup, LLC. It received FDA 510(k) clearance on 2005-03-30 under 510(k) number K040335. 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 MOONCUP, STYLE A & B?

MOONCUP, STYLE A & B is a medical device that received FDA 510(k) clearance on 2005-03-30. The listed applicant is Mooncup, LLC. The 510(k) number is K040335.

When did MOONCUP, STYLE A & B receive FDA 510(k) clearance?

MOONCUP, STYLE A & B received FDA 510(k) clearance on 2005-03-30, under 510(k) number K040335.

Who is the listed applicant for MOONCUP, STYLE A & B?

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

What is the FDA product code for MOONCUP, STYLE A & B?

The FDA product code for MOONCUP, STYLE A & B is HHE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: HHE)

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.

K233361Sunny Cup and ApplicatorMenstrual MatesK121857FEMMYCYCLEFemcap IncorporatedK120107SCKOONCUPSckoon, Inc.K112165RHEA CUPApex Medical Technologies, Inc.K092985BELLECUPLibrette, Inc.K091754LUNETTE MENSTRUAL CUP, MODELS 1 AND 2Lune Group , 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.

↑