510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041995Substantially Equivalent

Modification to: Gp General Purpose Drainage Catheter, Mini-Pig Drainage Catheter, Nephrostomy Catheter, Biliary

Uresil, LLC, Skokie IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K041995 is the FDA 510(k) clearance record for MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY, a class I device, cleared for Uresil, LLC on under FDA product code GBO (Catheter, Nephrostomy, General & Plastic Surgery). FDA records list 49 510(k) clearances for Uresil, LLC, from to . As of , FDA records show no recalls naming K041995.

Clearance record

Decision date
Received
(27 days to decision)
Product code
GBO Catheter, Nephrostomy, General & Plastic Surgery
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Uresil, LLC 5418 W. Touhy Ave., Skokie IL
510(k) summary
Statement
Third party review
No

Clearances, product code GBO

Trailing 12 months

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

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