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510(k) K233094

Wellead® Latex Foley Catheter by Well Lead Medical (Hainan) Co., Ltd. — Product Code MJC

K233094 is an FDA 510(k) premarket notification submitted by Well Lead Medical (Hainan) Co., Ltd. for the device "Wellead® Latex Foley Catheter". The FDA issued a decision of Substantially Equivalent on June 6, 2024. The device falls under product code MJC (Catheter, Urological (Antimicrobial) And Accessories), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2024
Date Received
September 26, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological (Antimicrobial) And Accessories
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances for product code MJC

  • K040658 — BARDEX I.C. LATEX FOLEY CATHETER (September 29, 2004)
  • K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SY (June 10, 2004)
  • K000251 — SPECTRUM SILICONE FOLEY CATHETER (August 30, 2000)
  • K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (July 7, 2000)
  • K993464 — BARDEX I.C. PEDIATRIC FOLEY CATHETER (December 10, 1999)
  • K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETER (February 16, 1999)
  • K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (November 3, 1998)
  • K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER (January 13, 1998)
  • K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (August 18, 1994)

FDA data resources