510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833245Substantially Equivalent

Security Stretch Brief-Medical

Mb Products, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833245 is the FDA 510(k) clearance record for SECURITY STRETCH BRIEF-MEDICAL, a class II device, cleared for Mb Products, Ltd. on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list one 510(k) clearance for Mb Products, Ltd. As of , FDA records show no recalls naming K833245.

Clearance record

Decision date
Received
(48 days to decision)
Product code
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mb Products, Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KNX

Trailing 12 months

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

FDA records show no clearances under product code KNX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNX, 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