FDA 510(k)

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

N.º K: K251274 · 2026-01-29

Fecha de decisión2026-01-29

Código de productoEZD

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is the device name listed in this FDA 510(k) record. The listed applicant is HR Healthcare. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251274. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is HR Healthcare. The 510(k) number is K251274.

When did EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits receive FDA 510(k) clearance?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251274.

Who is the listed applicant for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

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

What is the FDA product code for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

The FDA product code for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is EZD.

Ensayos clínicos relacionados

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Otros registros que enlistan a HR Healthcare como solicitante

K260502Liv Pre-lubricated Intermittent Catheter

Dispositivos relacionados (Código: EZD)

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

Fuente oficial

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