EXD — Irrigator, Ostomy Class II
FDA product code EXD covers "Irrigator, Ostomy", a Class II medical device regulated under 21 CFR 876.5895. Submissions are reviewed by the Gastroenterology, Urology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EXD
- Device Class
- Class II
- Regulation Number
- 876.5895
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K121833 | coloplast | OSTOMY IRRIGATION SET | July 16, 2012 |
| K914692 | cook urological | URINARY DIVERSION EVACUATING CATHETER | July 2, 1992 |
| K904586 | palex intl | PALEX IRRIGATION SET | December 28, 1990 |
| K871791 | i.b. bloxom c/o hogan and hartson | BLOXOM IRRIGATOR | May 20, 1987 |
| K840268 | coloplast | IRRIGATION SYSTEM | April 5, 1984 |
| K832299 | convatec, a division of e.r. squibb and sons | VISI-FLOW IRRIGATOR | August 26, 1983 |
| K823274 | howmedica | UNI-TIP COLOSTOMY IRRIGATION CONE | December 7, 1982 |
| K811160 | e. r. squibb and sons | SUR-FIT IRRIGATION SLEEVE | June 2, 1981 |
| K790749 | vabar | COLOSTOMY ENEMA DEVICE | May 16, 1979 |
| K790750 | vabar | COLOSTOMY DEVICE W/ PRESSURE LID | May 14, 1979 |
| K770251 | qualitone | SUPER X ADJUSTRETTE | February 28, 1977 |
| K760810 | sherwood medical industries | TUBE, GASTRO-ENTEROSTOMY | February 28, 1977 |