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510(k) K213283

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter by Convatec Limited — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2022
Date Received
October 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Convatec Limited

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  • K180205 — AVELLE Negative Pressure Wound Therapy System (October 19, 2018)
  • K181206 — GentleCath Glide Intermittent Urinary Catheter (August 16, 2018)
  • K173675 — AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fib (July 20, 2018)
  • K172924 — GentleCath Intermittent Urinary Catheter (November 21, 2017)
  • K161344 — GentleCath Glide Intermittent Catheter (September 20, 2016)
  • K152926 — AQUACEL Ag Surgical SP Dressing (January 21, 2016)

Other clearances for product code GBM

  • K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic In (March 5, 2025)
  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
  • K200820 — SpeediCath Compact Set (November 13, 2020)
  • K192904 — SpeediCath Compact Set (November 2, 2020)
  • K200142 — SpeediCath Soft (July 30, 2020)
  • K200134 — Jimushi Sterile Urethral Catheter for single use (June 1, 2020)
  • K191512 — LotusCatheter (Lotus No Balloon Catheter) (May 21, 2020)
  • K192577 — Actreen Hi-Lite Intermittent Urinary Catheters (May 7, 2020)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)
  • K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to (November 27, 2019)