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FDA 510(k)

Folysil Silicone Catheter

K-Number: K233411 · 2024-04-15

ApplicantColoplast Corp.
Decision Date2024-04-15
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Folysil Silicone Catheter is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2024-04-15 under approval number K233411. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Folysil Silicone Catheter?

Folysil Silicone Catheter is a medical device that received FDA 510(k) clearance on 2024-04-15. It is manufactured by Coloplast Corp.. The 510(k) number is K233411.

When was Folysil Silicone Catheter approved by the FDA?

Folysil Silicone Catheter received FDA 510(k) clearance on 2024-04-15, under approval number K233411.

What company makes Folysil Silicone Catheter?

Folysil Silicone Catheter is manufactured by Coloplast Corp..

What is the FDA product code for Folysil Silicone Catheter?

The FDA product code for Folysil Silicone Catheter is EZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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