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FDA 510(k)

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

K-Number: K241734 · 2025-03-05

ApplicantWell Lead Medical Co., Ltd.
Decision Date2025-03-05
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-05 under approval number K241734. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K241734.

When was Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact approved by the FDA?

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact received FDA 510(k) clearance on 2025-03-05, under approval number K241734.

What company makes Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

The FDA product code for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is GBM.

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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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