510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934419Substantially Equivalent

Ureteral Catheter and Accessories

Urological Associates of Central Jersey P.A., South Plainfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934419 is the FDA 510(k) clearance record for URETERAL CATHETER AND ACCESSORIES, a class I device, cleared for Urological Associates of Central Jersey P.A. on under FDA product code EYK (Connector, Ureteral Catheter). FDA records list one 510(k) clearance for Urological Associates of Central Jersey P.A. As of , FDA records show no recalls naming K934419.

Clearance record

Decision date
Received
(254 days to decision)
Product code
EYK Connector, Ureteral Catheter
Regulation
21 CFR 876.5130
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Urological Associates of Central Jersey P.A. 904 Oak Tree Rd., South Plainfield NJ
510(k) summary
Summary
Third party review
No

Clearances, product code EYK

Trailing 12 months

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

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