EZP · Rod, Colostomy
Gastroenterology, Urology · 21 CFR 876.4270 · Class 2
Overview
| Product Code | EZP |
|---|---|
| Device Name | Rod, Colostomy |
| Regulation | 21 CFR 876.4270 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening.
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.
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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052229 | COLOPLAST OSTOMY ROD, MODEL 12814 | Coloplast Corp. | Oct 13, 2006 | SESE |
| K040110 | EASY LOOP, MODEL EZL-01 | Tools For Surgery, LLC | Mar 24, 2004 | SESE |
Top Applicants
- Tools For Surgery, LLC — 1 clearance
- Coloplast Corp. — 1 clearance
