KPH · Catheter, Rectal For Continent Ileostomy
Gastroenterology, Urology · 21 CFR 876.5030 · Class 1
Overview
| Product Code | KPH |
|---|---|
| Device Name | Catheter, Rectal For Continent Ileostomy |
| Regulation | 21 CFR 876.5030 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A continent ileostomy catheter is a flexible tubular device used as a form during surgery for continent ileostomy and it provides drainage after surgery. Additionally, the device may be inserted periodically by the patient for routine care to empty the ileal pouch. This generic type of device includes the rectal catheter for continent ileostomy.
Classification Rationale
Class I (general 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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K813494 | WATERS ILEAL RESERVOIR CATHETER | Waters Instruments, Inc. | Dec 31, 1981 | SESE |
Top Applicants
- Waters Instruments, Inc. — 1 clearance
