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 Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

K-Number: K252943 · 2026-04-01

ApplicantConvatec Limited
Decision Date2026-04-01
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2026-04-01 under approval number K252943. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Convatec Limited. The 510(k) number is K252943.

When was GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women approved by the FDA?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women received FDA 510(k) clearance on 2026-04-01, under approval number K252943.

What company makes GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is manufactured by Convatec Limited.

What is the FDA product code for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

The FDA product code for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is EZD.

Related Clinical Trials

NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT03417960 Accelerated iTBS for Post Partum Depression RECRUITING NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT07019610 Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial NOT_YET_RECRUITING NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. 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 K181206GentleCath Glide Intermittent Urinary Catheter K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

View all 10 devices →

Related Devices (Code: EZD)

K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc. K160858CompactCath Intermittent Urinary CatheterCompactcath, Inc. K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)Zhanjiang Star Enterprise Co., Ltd. K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.

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.

↑