FDA 510(k)

Sagami Original 002 Polyurethane Male Condom

N.º K: K252158 · 2026-03-30

Fecha de decisión2026-03-30

Código de productoMOL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sagami Original 002 Polyurethane Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K252158. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sagami Original 002 Polyurethane Male Condom?

Sagami Original 002 Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Mayer Laboratories. The 510(k) number is K252158.

When did Sagami Original 002 Polyurethane Male Condom receive FDA 510(k) clearance?

Sagami Original 002 Polyurethane Male Condom received FDA 510(k) clearance on 2026-03-30, under 510(k) number K252158.

Who is the listed applicant for Sagami Original 002 Polyurethane Male Condom?

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

What is the FDA product code for Sagami Original 002 Polyurethane Male Condom?

The FDA product code for Sagami Original 002 Polyurethane Male Condom is MOL.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: MOL)

K243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLC K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited K231908Condón de Polisorbato de 45 MicronesSuretex Limited

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.