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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 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 2022-12-16 under 510(k) 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. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K220036.

When did Wellead Ureteral Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Wellead Ureteral Catheter?

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 Ureteral Catheter?

The FDA product code for Wellead Ureteral Catheter is KOD.

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

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactK220722PVC Hydrophilic Urethral CatheterK211543Wei Nasal Jet TubeK211814Wellead Endoscopic SealK202134Well Lead All Silicone Foley Catheter with Temperature SensorK203119ClearPetra Suction-Evacuation Sheath

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.K181144Angled Tip Ureteral CatheterCook Incorporated

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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