EXD · Irrigator, Ostomy
Gastroenterology, Urology · 21 CFR 876.5895 · Class 2
Overview
| Product Code | EXD |
|---|---|
| Device Name | Irrigator, Ostomy |
| Regulation | 21 CFR 876.5895 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
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.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121833 | OSTOMY IRRIGATION SET | Coloplast A/S | Jul 16, 2012 | SESE |
| K914692 | URINARY DIVERSION EVACUATING CATHETER | Cook Urological, Inc. | Jul 2, 1992 | SESE |
| K904586 | PALEX IRRIGATION SET | Palex Intl. SA | Dec 28, 1990 | SESE |
| K871791 | BLOXOM IRRIGATOR | I.B. Bloxom C/O Hogan & Hartson | May 20, 1987 | SESE |
| K840268 | IRRIGATION SYSTEM | Coloplast A/S | Apr 5, 1984 | SESE |
| K832299 | VISI-FLOW IRRIGATOR | Convatec, A Division of E.R. Squibb & Sons | Aug 26, 1983 | SESE |
| K823274 | UNI-TIP COLOSTOMY IRRIGATION CONE | Howmedica Corp. | Dec 7, 1982 | SESE |
| K811160 | SUR-FIT IRRIGATION SLEEVE | E. R. Squibb & Sons, Inc. | Jun 2, 1981 | SESE |
| K790749 | COLOSTOMY ENEMA DEVICE | Vabar Corp. | May 16, 1979 | SESE |
| K790750 | COLOSTOMY DEVICE W/ PRESSURE LID | Vabar Corp. | May 14, 1979 | SESE |
| K770251 | SUPER X ADJUSTRETTE | Qualitone | Feb 28, 1977 | SESE |
| K760810 | TUBE, GASTRO-ENTEROSTOMY | Sherwood Medical Industries | Feb 28, 1977 | SESE |
Top Applicants
- Coloplast A/S — 2 clearances
- Vabar Corp. — 2 clearances
- Convatec, A Division of E.R. Squibb & Sons — 1 clearance
- Cook Urological, Inc. — 1 clearance
- E. R. Squibb & Sons, Inc. — 1 clearance
