510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182511Substantially Equivalent

SimplCath

F&S Medical Solutions, LLC, Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182511 is the FDA 510(k) clearance record for SimplCath, a class II device, cleared for F&S Medical Solutions, LLC on under FDA product code GBM (Catheter, Urethral). FDA records list one 510(k) clearance for F&S Medical Solutions, LLC. As of , FDA records show no recalls naming K182511.

Clearance record

Decision date
Received
(189 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
F&S Medical Solutions, LLC 10221 Woodridge Ln., Omaha NE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

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