510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981344Substantially Equivalent

Uresil Percutaneous Drainage Catheters with Hydrophilic Coating

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

K981344 is the FDA 510(k) clearance record for URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING, cleared for Uresil Corp. on under FDA product code LJE (Catheter, Nephrostomy). FDA records list 49 510(k) clearances for Uresil Corp., from to . As of , FDA records show no recalls naming K981344.

Clearance record

Decision date
Received
(154 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
Uresil Corp. 5418 W. Touhy Ave., Skokie IL
510(k) summary
Statement
Third party review
No

Clearances, product code LJE

Trailing 12 months

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

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