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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 the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-05 under 510(k) 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. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K241734.

When did Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact receive FDA 510(k) clearance?

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

Who is the listed applicant for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Well Lead Medical Co., Ltd. as applicant

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Related Devices (Code: GBM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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