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FDA 510(k)

Silicone Urethral Catheter (Silicone Urethral Catheter)

K-Number: K243011 · 2025-06-16

ApplicantGuangdong Ecan Medical Co., Ltd.
Decision Date2025-06-16
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Silicone Urethral Catheter (Silicone Urethral Catheter) is a medical device manufactured by Guangdong Ecan Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-16 under approval number K243011. 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 Silicone Urethral Catheter (Silicone Urethral Catheter)?

Silicone Urethral Catheter (Silicone Urethral Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-16. It is manufactured by Guangdong Ecan Medical Co., Ltd.. The 510(k) number is K243011.

When was Silicone Urethral Catheter (Silicone Urethral Catheter) approved by the FDA?

Silicone Urethral Catheter (Silicone Urethral Catheter) received FDA 510(k) clearance on 2025-06-16, under approval number K243011.

What company makes Silicone Urethral Catheter (Silicone Urethral Catheter)?

Silicone Urethral Catheter (Silicone Urethral Catheter) is manufactured by Guangdong Ecan Medical Co., Ltd..

What is the FDA product code for Silicone Urethral Catheter (Silicone Urethral Catheter)?

The FDA product code for Silicone Urethral Catheter (Silicone Urethral 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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