FDA product code EXD: Irrigator, Ostomy
EXD is the FDA product code for irrigator, ostomy. It is a Class II device, regulated under 21 CFR 876.5895 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under EXD, from 10 different applicants. The average 510(k) review took 65 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Irrigator, Ostomy |
| Device class | Class II |
| Regulation | 21 CFR 876.5895 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EXD clearance
Top EXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast A/S | 2 | 2012-07-16 |
| Vabar Corp. | 2 | 1979-05-16 |
| Cook Urological, Inc. | 1 | 1992-07-02 |
| Palex Intl. SA | 1 | 1990-12-28 |
| I.B. Bloxom C/O Hogan & Hartson | 1 | 1987-05-20 |
5 more applicants have EXD clearances. See the full list in Caduvo.
Most recent EXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121833 | Coloplast A/S | OSTOMY IRRIGATION SET | 2012-07-16 | 24 |
| K914692 | Cook Urological, Inc. | URINARY DIVERSION EVACUATING CATHETER | 1992-07-02 | 258 |
| K904586 | Palex Intl. SA | PALEX IRRIGATION SET | 1990-12-28 | 80 |
| K871791 | I.B. Bloxom C/O Hogan & Hartson | BLOXOM IRRIGATOR | 1987-05-20 | 13 |
| K840268 | Coloplast A/S | IRRIGATION SYSTEM | 1984-04-05 | 73 |
Recalls for EXD devices
openFDA lists no recalls for product code EXD.
Frequently asked questions
What is FDA product code EXD?
EXD is the FDA product code for irrigator, ostomy. It is a Class II device, regulated under 21 CFR 876.5895 and reviewed by the Gastroenterology and Urology panel.
What device class is EXD?
Class II, regulation 21 CFR 876.5895. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXD?
Across 12 cleared submissions the average was 65 days from receipt to decision (median 34).
Which companies have the most EXD clearances?
Coloplast A/S (2); Vabar Corp. (2); Cook Urological, Inc. (1); Palex Intl. SA (1); I.B. Bloxom C/O Hogan & Hartson (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EXD
- Run a recall and safety report across every EXD manufacturer
- Watch product code EXD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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