510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K823382Substantially Equivalent

Nephrostomy Catheter

Umi, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823382 is the FDA 510(k) clearance record for NEPHROSTOMY CATHETER, cleared for Umi, Inc. on under FDA product code LJE (Catheter, Nephrostomy). FDA records list 3 510(k) clearances for Umi, Inc., from to . As of , FDA records show no recalls naming K823382.

Clearance record

Decision date
Received
(77 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
Umi, Inc. 803 N. Front St. Suite 3, Mchenry IL
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