Product code EXD

Device name: Irrigator, Ostomy
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5895
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K121833	OSTOMY IRRIGATION SET	Coloplast A/S	2012-07-16
K914692	URINARY DIVERSION EVACUATING CATHETER	Cook Urological, Inc.	1992-07-02
K904586	PALEX IRRIGATION SET	Palex Intl. SA	1990-12-28
K871791	BLOXOM IRRIGATOR	I.B. Bloxom C/O Hogan & Hartson	1987-05-20
K840268	IRRIGATION SYSTEM	Coloplast A/S	1984-04-05
K832299	VISI-FLOW IRRIGATOR	Convatec, A Division of E.R. Squibb & Sons	1983-08-26
K823274	UNI-TIP COLOSTOMY IRRIGATION CONE	Howmedica Corp.	1982-12-07
K811160	SUR-FIT IRRIGATION SLEEVE	E. R. Squibb & Sons, Inc.	1981-06-02
K790749	COLOSTOMY ENEMA DEVICE	Vabar Corp.	1979-05-16
K790750	COLOSTOMY DEVICE W/ PRESSURE LID	Vabar Corp.	1979-05-14
K760810	TUBE, GASTRO-ENTEROSTOMY	Sherwood Medical Industries	1977-02-28
K770251	SUPER X ADJUSTRETTE	Qualitone	1977-02-28

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00610075077243	Hollister	HOLLISTER INCORPORATED	2022-12-01
00610075077281	Hollister	HOLLISTER INCORPORATED	2022-12-01
00610075181520	New Image	HOLLISTER INCORPORATED	2022-12-01
00610075181537	New Image	HOLLISTER INCORPORATED	2022-12-01
00610075181544	New Image	HOLLISTER INCORPORATED	2022-12-01
00842071118877	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118747	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118761	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118785	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118792	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118815	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118839	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118853	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118860	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118686	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118884	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118907	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118921	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118716	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118693	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118655	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118631	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118600	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118587	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118563	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00842071118549	MiniACE™ Low Profile Antegrade Continence Enema Button	APPLIED MEDICAL TECHNOLOGY, INC.	2018-07-02
00610075077212	Hollister	HOLLISTER INCORPORATED	2016-09-21
00610075077236	Hollister	HOLLISTER INCORPORATED	2016-09-21
00762123023433	Assura	Coloplast A/S	2016-09-14
00762123021354	Assura	Coloplast A/S	2016-09-14

Product code EXD

Related 510(k) Records#

Related GUDID Devices#