EXD
12 FDA 510(k) clearances · Product code
35 daysmedian time to decision
149 days90th percentile
12clearances measured
FDA profile
- Official device name
- Irrigator, Ostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5895
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 1 · 1995: 1 · 2000: 1 · 2008: 2 · 2018: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OSTOMY IRRIGATION SET (K121833) | Coloplast A/S | 2012-07-16 |
| URINARY DIVERSION EVACUATING CATHETER (K914692) | Cook Urological, Inc. | 1992-07-02 |
| PALEX IRRIGATION SET (K904586) | Palex Intl. SA | 1990-12-28 |
| BLOXOM IRRIGATOR (K871791) | I.B. Bloxom C/O Hogan & Hartson | 1987-05-20 |
| IRRIGATION SYSTEM (K840268) | Coloplast A/S | 1984-04-05 |
| VISI-FLOW IRRIGATOR (K832299) | Convatec, A Division of E.R. Squibb & Sons | 1983-08-26 |
| UNI-TIP COLOSTOMY IRRIGATION CONE (K823274) | Howmedica Corp. | 1982-12-07 |
| SUR-FIT IRRIGATION SLEEVE (K811160) | E. R. Squibb & Sons, Inc. | 1981-06-02 |
| COLOSTOMY ENEMA DEVICE (K790749) | Vabar Corp. | 1979-05-16 |
| COLOSTOMY DEVICE W/ PRESSURE LID (K790750) | Vabar Corp. | 1979-05-14 |
| TUBE, GASTRO-ENTEROSTOMY (K760810) | Sherwood Medical Industries | 1977-02-28 |
| SUPER X ADJUSTRETTE (K770251) | Qualitone | 1977-02-28 |
Track EXD automatically
Every clearance here is in the API, with alerts when new ones post.