Irrigator, Ostomy
The ostomy irrigator is a device used by colostomy patients to instill water into the stoma to stimulate bowel evacuation at regular intervals, providing an alternative to wearing a collection pouch continuously. It is classified as FDA Class 2, indicating moderate risk, and requires special controls. The product code is EXD, regulated under 21 CFR 876.5895 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
Basic Information
- Product Code
- EXD
- Device Class
- FDA class 2
- Regulation Number
- 876.5895
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121833 | OSTOMY IRRIGATION SET | Jul 16, 2012 | Substantially Equivalent | COLOPLAST A/S |
| K914692 | URINARY DIVERSION EVACUATING CATHETER | Jul 02, 1992 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K904586 | PALEX IRRIGATION SET | Dec 28, 1990 | Substantially Equivalent | PALEX INTL. SA |
| K871791 | BLOXOM IRRIGATOR | May 20, 1987 | Substantially Equivalent | I.B. BLOXOM C/O HOGAN & HARTSON |
| K840268 | IRRIGATION SYSTEM | Apr 05, 1984 | Substantially Equivalent | COLOPLAST A/S |
| K832299 | VISI-FLOW IRRIGATOR | Aug 26, 1983 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K823274 | UNI-TIP COLOSTOMY IRRIGATION CONE | Dec 07, 1982 | Substantially Equivalent | HOWMEDICA CORP. |
| K811160 | SUR-FIT IRRIGATION SLEEVE | Jun 02, 1981 | Substantially Equivalent | E. R. SQUIBB & SONS, INC. |
| K790749 | COLOSTOMY ENEMA DEVICE | May 16, 1979 | Substantially Equivalent | VABAR CORP. |
| K790750 | COLOSTOMY DEVICE W/ PRESSURE LID | May 14, 1979 | Substantially Equivalent | VABAR CORP. |
| K770251 | SUPER X ADJUSTRETTE | Feb 28, 1977 | Substantially Equivalent | QUALITONE |
| K760810 | TUBE, GASTRO-ENTEROSTOMY | Feb 28, 1977 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.