Cleared Traditional

K904586 - PALEX IRRIGATION SET
(FDA 510(k) Clearance)

K904586 · Palex Intl. SA · Gastroenterology & Urology
Dec 1990
Decision
80d
Days
Class 2
Risk

K904586 is an FDA 510(k) clearance for the PALEX IRRIGATION SET. This device is classified as a Irrigator, Ostomy (Class II — Special Controls, product code EXD).

Submitted by Palex Intl. SA (Spain, ES). The FDA issued a Cleared decision on December 28, 1990, 80 days after receiving the submission on October 9, 1990.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5895.

Submission Details

510(k) Number K904586 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1990
Decision Date December 28, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EXD — Irrigator, Ostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5895