EXDClass II
Irrigator, Ostomy
21 CFR 876.5895 / Gastroenterology, Urology
EXD is the FDA product code for Irrigator, Ostomy, a class II device type, regulated under 21 CFR 876.5895. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EXD
- Device name
- Irrigator, Ostomy
- Regulation
- 21 CFR 876.5895
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 12
- Ingested recalls
- 0
Clearances, product code EXD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1979 | 2 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1987 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code EXD| Applicant | Clearances |
|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 2 |
| Vabar Corp. | 2 |
| Convatec, A Division of E.R. Squibb & Sons | 1 |
| Cook Incorporated | 1 |
| E. R. Squibb & Sons, Inc. | 1 |
| Howmedica Corp. | 1 |
| I.B. Bloxom C/O Hogan & Hartson | 1 |
| Palex Intl. SA | 1 |
| Qualitone | 1 |
| Sherwood Medical Industries | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.