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FDA 510(k)

GentleCath Glide Intermittent Catheter

K-Number: K161344 · 2016-09-20

ApplicantConvatec Limited
Decision Date2016-09-20
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GentleCath Glide Intermittent Catheter is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2016-09-20 under approval number K161344. 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 Glide Intermittent Catheter?

GentleCath Glide Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2016-09-20. It is manufactured by Convatec Limited. The 510(k) number is K161344.

When was GentleCath Glide Intermittent Catheter approved by the FDA?

GentleCath Glide Intermittent Catheter received FDA 510(k) clearance on 2016-09-20, under approval number K161344.

What company makes GentleCath Glide Intermittent Catheter?

GentleCath Glide Intermittent Catheter is manufactured by Convatec Limited.

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

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

Related Clinical Trials

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Other Devices by Convatec Limited

K152926AQUACEL Ag Surgical SP Dressing K172924GentleCath Intermittent Urinary Catheter K180205AVELLE Negative Pressure Wound Therapy System K181206GentleCath Glide Intermittent Urinary Catheter K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

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Related Devices (Code: KOD)

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 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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