FDA 510(k)

InnoCare Specialty Foley Catheter

Numéro K : K241424 · 2024-09-18

Date de décision2024-09-18

Code produitEZL

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

InnoCare Specialty Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innocare Urologics, LLC. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K241424. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the InnoCare Specialty Foley Catheter?

InnoCare Specialty Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Innocare Urologics, LLC. The 510(k) number is K241424.

When did InnoCare Specialty Foley Catheter receive FDA 510(k) clearance?

InnoCare Specialty Foley Catheter received FDA 510(k) clearance on 2024-09-18, under 510(k) number K241424.

Who is the listed applicant for InnoCare Specialty Foley Catheter?

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

What is the FDA product code for InnoCare Specialty Foley Catheter?

The FDA product code for InnoCare Specialty Foley Catheter is EZL.

Essais cliniques associés

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Dispositifs connexes (Code : EZL)

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Source officielle

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