510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233094Substantially Equivalent

Wellead® Latex Foley Catheter

Well Lead Medical (Hainan) Co., Ltd., Haikou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233094 is the FDA 510(k) clearance record for Wellead® Latex Foley Catheter, a class II device, cleared for Well Lead Medical (Hainan) Co., Ltd. on under FDA product code MJC (Catheter, Urological (Antimicrobial) And Accessories). FDA records list one 510(k) clearance for Well Lead Medical (Hainan) Co., Ltd. As of , FDA records show no recalls naming K233094.

Clearance record

Decision date
Received
(254 days to decision)
Product code
MJC Catheter, Urological (Antimicrobial) And Accessories
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Well Lead Medical (Hainan) Co., Ltd. # 39, Mei'An 3rd St., Mei'An Ecological, Haikou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJC

Trailing 12 months

FDA records hold no clearances under product code MJC in the trailing twelve months.

FDA records show no clearances under product code MJC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260