Panels › Gastroenterology, Urology › Product code EXD · Class 2
Irrigator, Ostomy
Regulation 876.5895
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EXD
| Company | 510(k)s | Recalls |
|---|---|---|
| Coloplast A/S | 2 | 0 |
| Vabar Corp. | 2 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 1 | 0 |
| Cook Urological, Inc. | 1 | 0 |
| E. R. Squibb & Sons, Inc. | 1 | 0 |
| Howmedica Corp. | 1 | 0 |
| I.B. Bloxom C/O Hogan & Hartson | 1 | 0 |
| Palex Intl. SA | 1 | 0 |
| Qualitone | 1 | 0 |
| Sherwood Medical Industries | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2012 | K121833 | OSTOMY IRRIGATION SET Coloplast A/S | EXD |
| Jul 2, 1992 | K914692 | URINARY DIVERSION EVACUATING CATHETER Cook Urological, Inc. | EXD |
| Dec 28, 1990 | K904586 | PALEX IRRIGATION SET Palex Intl. SA, ES | EXD |
| May 20, 1987 | K871791 | BLOXOM IRRIGATOR I.B. Bloxom C/O Hogan & Hartson | EXD |
| Apr 5, 1984 | K840268 | IRRIGATION SYSTEM Coloplast A/S | EXD |
| Aug 26, 1983 | K832299 | VISI-FLOW IRRIGATOR Convatec, A Division of E.R. Squibb & Sons | EXD |
| Dec 7, 1982 | K823274 | UNI-TIP COLOSTOMY IRRIGATION CONE Howmedica Corp. | EXD |
| Jun 2, 1981 | K811160 | SUR-FIT IRRIGATION SLEEVE E. R. Squibb & Sons, Inc. | EXD |
| May 16, 1979 | K790749 | COLOSTOMY ENEMA DEVICE Vabar Corp. | EXD |
| May 14, 1979 | K790750 | COLOSTOMY DEVICE W/ PRESSURE LID Vabar Corp. | EXD |
| Feb 28, 1977 | K770251 | SUPER X ADJUSTRETTE Qualitone | EXD |
| Feb 28, 1977 | K760810 | TUBE, GASTRO-ENTEROSTOMY Sherwood Medical Industries | EXD |
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