21 CFR 876.5895 — Irrigator, Ostomy
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5895
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EXD | Irrigator, Ostomy | 2 | 12 |
Special Controls
EXD — Irrigator, Ostomy
*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.
eCFR
