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FDA 510(k)

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

K-Number: K232665 · 2024-01-25

ApplicantConvatec
Decision Date2024-01-25
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is a medical device manufactured by Convatec. It received FDA 510(k) clearance on 2024-01-25 under approval number K232665. 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 Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)?

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is a medical device that received FDA 510(k) clearance on 2024-01-25. It is manufactured by Convatec. The 510(k) number is K232665.

When was GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) approved by the FDA?

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) received FDA 510(k) clearance on 2024-01-25, under approval number K232665.

What company makes GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)?

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is manufactured by Convatec.

What is the FDA product code for GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)?

The FDA product code for GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) is EZD.

Other Devices by Convatec

K162906Flexi-Seal PROTECT Fecal Management System K250699Cure 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) K243228Flexi-Seal AIR (with ENFit Connector)

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.

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