510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041416Substantially Equivalent

Exac-Temp Foley Catheter and Clini-Temp Foley Catheter

Deroyal, Powell TN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K041416 is the FDA 510(k) clearance record for EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER, a class II device, cleared for Deroyal on under FDA product code EYC (Catheter, Upper Urinary Tract). FDA records list 5 510(k) clearances for Deroyal, from to . As of , FDA records show no recalls naming K041416.

Clearance record

Decision date
Received
(36 days to decision)
Product code
EYC Catheter, Upper Urinary Tract
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Deroyal 200 Debusk Ln., Powell TN
510(k) summary
Statement
Third party review
No

Clearances, product code EYC

Trailing 12 months

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

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