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 the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical (Hainan) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) 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. The listed applicant is Well Lead Medical (Hainan) Co., Ltd.. The 510(k) number is K233094.
When did Wellead® Latex Foley Catheter receive FDA 510(k) clearance?
Wellead® Latex Foley Catheter received FDA 510(k) clearance on 2024-06-06, under 510(k) number K233094.
Who is the listed applicant for Wellead® Latex Foley Catheter?
The FDA 510(k) record lists Well Lead Medical (Hainan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wellead® Latex Foley Catheter?
The FDA product code for Wellead® Latex Foley Catheter is MJC.
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.