PALEX IRRIGATION SET
Device Facts
| Record ID | K904586 |
|---|---|
| Device Name | PALEX IRRIGATION SET |
| Applicant | Palex Intl. SA |
| Product Code | EXD · Gastroenterology, Urology |
| Decision Date | Dec 28, 1990 |
| 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.
