510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904586Substantially Equivalent

Palex Irrigation Set

Palex Intl. SA, Spain, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904586 is the FDA 510(k) clearance record for PALEX IRRIGATION SET, a class II device, cleared for Palex Intl. SA on under FDA product code EXD (Irrigator, Ostomy). FDA records list 5 510(k) clearances for Palex Intl. SA, from to . As of , FDA records show no recalls naming K904586.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EXD Irrigator, Ostomy
Regulation
21 CFR 876.5895
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Palex Intl. SA Carretera De Terrassa, 121, Spain, ES
Third party review
No

Clearances, product code EXD

Trailing 12 months

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

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