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FDA 510(k)

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

K-Number: K213283 · 2022-06-22

ApplicantConvatec Limited
Decision Date2022-06-22
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2022-06-22 under approval number K213283. 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 GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2022-06-22. It is manufactured by Convatec Limited. The 510(k) number is K213283.

When was GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter approved by the FDA?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter received FDA 510(k) clearance on 2022-06-22, under approval number K213283.

What company makes GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is manufactured by Convatec Limited.

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

The FDA product code for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is GBM.

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Related Devices (Code: GBM)

K161672SpeediCath Flex CoudeColoplast Corp. K160795United Urologics Intermittent CatheterRobling Medical K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc. K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated K163179Onli Intermittent CatheterHollister Incorporated K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister 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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