Wellead® Latex Foley Catheter
K-Number: K233094 · 2024-06-06
ApplicantWell Lead Medical (Hainan) Co., Ltd.
Decision Date2024-06-06
Product CodeMJC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Wellead® Latex Foley Catheter is a medical device manufactured by Well Lead Medical (Hainan) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-06 under approval number K233094. The device is classified under product code MJC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wellead® Latex Foley Catheter?
Wellead® Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-06-06. It is manufactured by Well Lead Medical (Hainan) Co., Ltd.. The 510(k) number is K233094.
When was Wellead® Latex Foley Catheter approved by the FDA?
Wellead® Latex Foley Catheter received FDA 510(k) clearance on 2024-06-06, under approval number K233094.
What company makes Wellead® Latex Foley Catheter?
Wellead® Latex Foley Catheter is manufactured by Well Lead Medical (Hainan) Co., Ltd..
What is the FDA product code for Wellead® Latex Foley Catheter?
The FDA product code for Wellead® Latex Foley Catheter is MJC.
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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.