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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 the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2016-09-20 under 510(k) 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. The listed applicant is Convatec Limited. The 510(k) number is K161344.

When did GentleCath Glide Intermittent Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for GentleCath Glide Intermittent Catheter?

The FDA 510(k) record lists Convatec Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Convatec Limited 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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenK250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CK243228Flexi-Seal AIR (with ENFit Connector)K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

View all 17 devices →

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.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.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.

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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