Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

N.º K: K161195 · 2016-08-25

SolicitanteM3 Global Enterprises, LLC
Fecha de decisión2016-08-25
Código de productoHIS
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is the device name listed in this FDA 510(k) record. The listed applicant is M3 Global Enterprises, LLC. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161195. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is M3 Global Enterprises, LLC. The 510(k) number is K161195.

When did Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) receive FDA 510(k) clearance?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161195.

Who is the listed applicant for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

The FDA 510(k) record lists M3 Global Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

The FDA product code for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is HIS.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Dispositivos relacionados (Código: HIS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑