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510(k) K243011

Silicone Urethral Catheter (Silicone Urethral Catheter) by Guangdong Ecan Medical Co., Ltd. — Product Code EZL

K243011 is an FDA 510(k) premarket notification submitted by Guangdong Ecan Medical Co., Ltd. for the device "Silicone Urethral Catheter (Silicone Urethral Catheter)". The FDA issued a decision of Substantially Equivalent on June 16, 2025. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2025
Date Received
September 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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FDA data resources