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FDA 510(k)

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

N.º K: K230049 · 2023-09-07

SolicitanteTtk Healthcare Limited
Fecha de decisión2023-09-07
Código de productoHIS
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT is the device name listed in this FDA 510(k) record. The listed applicant is Ttk Healthcare Limited. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K230049. 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 SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT?

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Ttk Healthcare Limited. The 510(k) number is K230049.

When did SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT receive FDA 510(k) clearance?

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT received FDA 510(k) clearance on 2023-09-07, under 510(k) number K230049.

Who is the listed applicant for SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT?

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

What is the FDA product code for SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT?

The FDA product code for SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT 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

Otros registros que enlistan a Ttk Healthcare Limited como solicitante

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.

K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE VanillaK202403SKORE (Colors & Flavors), SKORE (Colors)

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.

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