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FDA 510(k)

GentleCath Intermittent Urinary Catheter

K-Number: K172924 · 2017-11-21

ApplicantConvatec Limited
Decision Date2017-11-21
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GentleCath Intermittent Urinary Catheter is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2017-11-21 under approval number K172924. 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 GentleCath Intermittent Urinary Catheter?

GentleCath Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by Convatec Limited. The 510(k) number is K172924.

When was GentleCath Intermittent Urinary Catheter approved by the FDA?

GentleCath Intermittent Urinary Catheter received FDA 510(k) clearance on 2017-11-21, under approval number K172924.

What company makes GentleCath Intermittent Urinary Catheter?

GentleCath Intermittent Urinary Catheter is manufactured by Convatec Limited.

What is the FDA product code for GentleCath Intermittent Urinary Catheter?

The FDA product code for GentleCath Intermittent Urinary Catheter is KOD.

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Other Devices by Convatec Limited

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Related Devices (Code: KOD)

K161344GentleCath Glide Intermittent CatheterConvatec Limited K160877United Urologics Closed System CatheterRobling Medical, Inc. K180354UroGen Ureteral CatheterUrogen Pharma, Ltd. K181144Angled Tip Ureteral CatheterCook Incorporated K180530Imager II Urology Torque CatheterBoston Scientific Corporation K171810Cone Tip Ureteral Catheter, Rutner Universal Wedge 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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