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FDA 510(k)

Wellead Ureteral Catheter

K-Number: K220036 · 2022-12-16

ApplicantWell Lead Medical Co., Ltd.
Decision Date2022-12-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Wellead Ureteral Catheter is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under approval number K220036. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wellead Ureteral Catheter?

Wellead Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K220036.

When was Wellead Ureteral Catheter approved by the FDA?

Wellead Ureteral Catheter received FDA 510(k) clearance on 2022-12-16, under approval number K220036.

What company makes Wellead Ureteral Catheter?

Wellead Ureteral Catheter is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Wellead Ureteral Catheter?

The FDA product code for Wellead Ureteral Catheter is KOD.

Related Clinical Trials

NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K161110ClearPetra Suction-Evacuation Sheath K151084Well Lead Ureteral Access Sheath K162340Stomach Tube K182739Endotracheal Tube with Evacuation Lumen K203119ClearPetra Suction-Evacuation Sheath

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Related Devices (Code: KOD)

K161344GentleCath Glide Intermittent CatheterConvatec Limited K160877United Urologics Closed System CatheterRobling Medical, Inc. K172924GentleCath Intermittent Urinary CatheterConvatec Limited K180354UroGen Ureteral CatheterUrogen Pharma, Ltd. K181144Angled Tip Ureteral CatheterCook Incorporated K180530Imager II Urology Torque CatheterBoston Scientific Corporation

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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