EXD · Class II · 21 CFR 876.5895

FDA Product Code EXD: Irrigator, Ostomy

Leading manufacturers include Coloplast A/S, Vabar Corp. and Sherwood Medical Industries.

12
Total
12
Cleared
65d
Avg days
1977
Since

FDA 510(k) Cleared Irrigator, Ostomy Devices (Product Code EXD)

12 devices
1–12 of 12
Cleared Jul 16, 2012
OSTOMY IRRIGATION SET
K121833
Coloplast A/S
Gastroenterology & Urology · 24d
Cleared Jul 02, 1992
URINARY DIVERSION EVACUATING CATHETER
K914692
Cook Urological, Inc.
Gastroenterology & Urology · 258d
Cleared Dec 28, 1990
PALEX IRRIGATION SET
K904586
Palex Intl. SA
Gastroenterology & Urology · 80d
Cleared May 20, 1987
BLOXOM IRRIGATOR
K871791
I.B. Bloxom C/O Hogan & Hartson
Gastroenterology & Urology · 13d
Cleared Apr 05, 1984
IRRIGATION SYSTEM
K840268
Coloplast A/S
Gastroenterology & Urology · 73d
Cleared Aug 26, 1983
VISI-FLOW IRRIGATOR
K832299
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 44d
Cleared Dec 07, 1982
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274
Howmedica Corp.
Gastroenterology & Urology · 34d
Cleared Jun 02, 1981
SUR-FIT IRRIGATION SLEEVE
K811160
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared May 16, 1979
COLOSTOMY ENEMA DEVICE
K790749
Vabar Corp.
Gastroenterology & Urology · 29d
Cleared May 14, 1979
COLOSTOMY DEVICE W/ PRESSURE LID
K790750
Vabar Corp.
Gastroenterology & Urology · 27d
Cleared Feb 28, 1977
TUBE, GASTRO-ENTEROSTOMY
K760810
Sherwood Medical Industries
Gastroenterology & Urology · 149d
Cleared Feb 28, 1977
SUPER X ADJUSTRETTE
K770251
Qualitone
Gastroenterology & Urology · 19d

About Product Code EXD - Regulatory Context