Palex Irrigation Set

FDA 510(k) K904586 · Palex Intl. SA

Substantially Equivalent

510(k) numberK904586

Submission

Device name
Palex Irrigation Set
Applicant
Palex Intl. SA
Spain, ES
Received
October 9, 1990
Decision date
December 28, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EXD – Irrigator, Ostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5895
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EXD

510(k)DeviceApplicantDecision
K121833Ostomy Irrigation SetEXD · Special Coloplast A/S07/16/2012SE
K914692Urinary Diversion Evacuating CatheterEXD · Traditional Cook Urological, Inc.07/02/1992SE
K871791Bloxom IrrigatorEXD · Traditional I.B. Bloxom C/O Hogan & Hartson05/20/1987SE
K840268Irrigation SystemEXD · Traditional Coloplast A/S04/05/1984SE
K832299Visi-Flow IrrigatorEXD · Traditional Convatec, A Division of E.R. Squibb & Sons08/26/1983SE
K823274Uni-Tip Colostomy Irrigation ConeEXD · Traditional Howmedica Corp.12/07/1982SE
K811160Sur-Fit Irrigation SleeveEXD · Traditional E. R. Squibb & Sons, Inc.06/02/1981SE
K790749Colostomy Enema DeviceEXD · Traditional Vabar Corp.05/16/1979SE
K790750Colostomy Device W/ Pressure LidEXD · Traditional Vabar Corp.05/14/1979SE
K770251Super X AdjustretteEXD · Traditional Qualitone02/28/1977SE

More from Qualitone

510(k)DeviceDecision
K905108Contorno(R), Models E and STGEI · Traditional 02/04/1991SE
K903224EpisensorBSP · Traditional 12/24/1990SE
K902642Contorno (TM)GEI · Traditional 08/07/1990SE
K901680Bauman Rigid LaryngoscopeCCW · Traditional 07/12/1990SE

Questions and answers

When was Palex Irrigation Set cleared by the FDA?

Palex Irrigation Set (K904586) received a 510(k) decision of Substantially Equivalent on December 28, 1990, 80 days after the submission was received.

What is the product code of K904586?

The FDA product code is EXD – Irrigator, Ostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5895.