FDA Product Code
FDA Product Code EXD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5895
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K121833 | OSTOMY IRRIGATION SET | Coloplast A/S | 2012-07-16 | Special | PDF ↗ |
| K914692 | URINARY DIVERSION EVACUATING CATHETER | Cook Urological, Inc. | 1992-07-02 | Traditional | PDF ↗ |
| K904586 | PALEX IRRIGATION SET | Palex Intl. SA | 1990-12-28 | Traditional | PDF ↗ |
| K871791 | BLOXOM IRRIGATOR | I.B. Bloxom C/O Hogan & Hartson | 1987-05-20 | Traditional | PDF ↗ |
| K840268 | IRRIGATION SYSTEM | Coloplast A/S | 1984-04-05 | Traditional | PDF ↗ |
| K832299 | VISI-FLOW IRRIGATOR | Convatec, A Division of E.R. Squibb & Sons | 1983-08-26 | Traditional | PDF ↗ |
| K823274 | UNI-TIP COLOSTOMY IRRIGATION CONE | Howmedica Corp. | 1982-12-07 | Traditional | PDF ↗ |
| K811160 | SUR-FIT IRRIGATION SLEEVE | E. R. Squibb & Sons, Inc. | 1981-06-02 | Traditional | PDF ↗ |
| K790749 | COLOSTOMY ENEMA DEVICE | Vabar Corp. | 1979-05-16 | Traditional | PDF ↗ |
| K790750 | COLOSTOMY DEVICE W/ PRESSURE LID | Vabar Corp. | 1979-05-14 | Traditional | PDF ↗ |
| K770251 | SUPER X ADJUSTRETTE | Qualitone | 1977-02-28 | Traditional | PDF ↗ |
| K760810 | TUBE, GASTRO-ENTEROSTOMY | Sherwood Medical Industries | 1977-02-28 | Traditional | PDF ↗ |
Product code EXD · Class II · Gastroenterology, Urology. Data: openFDA.