Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GentleCath Glide Intermittent Urinary Catheter

K-Number: K181206 · 2018-08-16

ApplicantConvatec Limited
Decision Date2018-08-16
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GentleCath Glide Intermittent Urinary Catheter is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2018-08-16 under approval number K181206. 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 Glide Intermittent Urinary Catheter?

GentleCath Glide Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Convatec Limited. The 510(k) number is K181206.

When was GentleCath Glide Intermittent Urinary Catheter approved by the FDA?

GentleCath Glide Intermittent Urinary Catheter received FDA 510(k) clearance on 2018-08-16, under approval number K181206.

What company makes GentleCath Glide Intermittent Urinary Catheter?

GentleCath Glide Intermittent Urinary Catheter is manufactured by Convatec Limited.

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

The FDA product code for GentleCath Glide Intermittent Urinary Catheter is GBM.

Related Clinical Trials

NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED NCT05694793 Trial for Reliability of Urodynamics SysTem RECRUITING

Other Devices by Convatec Limited

K161344GentleCath Glide Intermittent Catheter K152926AQUACEL Ag Surgical SP Dressing K172924GentleCath Intermittent Urinary Catheter K180205AVELLE Negative Pressure Wound Therapy System K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

View all 10 devices →

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.

↑