510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834476Substantially Equivalent

Nephrostomy/biliary Drainage Bag

Vertex Medical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834476 is the FDA 510(k) clearance record for NEPHROSTOMY/BILIARY DRAINAGE BAG, cleared for Vertex Medical Corp. on under FDA product code LJE (Catheter, Nephrostomy). FDA records list 21 510(k) clearances for Vertex Medical Corp., from to . As of , FDA records show no recalls naming K834476.

Clearance record

Decision date
Received
(46 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
Vertex Medical Corp. 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