IRRIGATION SYSTEM
Device Facts
| Record ID | K840268 |
|---|---|
| Device Name | IRRIGATION SYSTEM |
| Applicant | Coloplast A/S |
| Product Code | EXD · Gastroenterology, Urology |
| Decision Date | Apr 5, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5895 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
