Home / 510(k) Clearances / K241734

510(k) K241734

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact by Well Lead Medical Co., Ltd. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2025
Date Received
June 17, 2024
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 Well Lead Medical Co., Ltd.

  • K220722 — PVC Hydrophilic Urethral Catheter (May 22, 2023)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)
  • K211814 — Wellead Endoscopic Seal (January 14, 2022)
  • K202134 — Well Lead All Silicone Foley Catheter with Temperature Sensor (April 8, 2021)
  • K203119 — ClearPetra Suction-Evacuation Sheath (December 9, 2020)
  • K182739 — Endotracheal Tube with Evacuation Lumen (December 11, 2019)
  • K162340 — Stomach Tube (October 11, 2017)
  • K160801 — Well Lead Extraction Bag (November 29, 2016)
  • K161110 — ClearPetra Suction-Evacuation Sheath (October 12, 2016)

Other clearances for product code GBM

  • K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (June 22, 2022)
  • 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)