FDA product code EZQ: Pouch, Colostomy
EZQ is the FDA product code for pouch, colostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under EZQ, from 5 different applicants. The average 510(k) review took 119 days (median 56). FDA has posted 5 recalls for EZQ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pouch, Colostomy |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EZQ clearance
Top EZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Convatec, Inc. | 2 | 2011-08-19 |
| Convatec | 1 | 2010-04-02 |
| Boston Pacific Medical, Inc. | 1 | 1992-06-10 |
| Marlen Mfg. & Development Co. | 1 | 1988-02-19 |
| Coloplast A/S | 1 | 1986-10-16 |
Most recent EZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111365 | Convatec, Inc. | VITALA CONTINENCE CONTROL DEVICE | 2011-08-19 | 95 |
| K102536 | Convatec, Inc. | VITALA CONTINENCE CONTROL DEVICE | 2010-12-01 | 89 |
| K083785 | Convatec | VITALA CONTINENCE CONTROL DEVICE | 2010-04-02 | 469 |
| K922401 | Boston Pacific Medical, Inc. | 4 SURE TM COLOSTOMY POUCH | 1992-06-10 | 20 |
| K880327 | Marlen Mfg. & Development Co. | MARLEN ULTRA ILEOSTOMY POUCH-5000 | 1988-02-19 | 24 |
Recalls for EZQ devices
5 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2022-08-16.
| Year | Recalls |
|---|---|
| 2022 | 4 |
Frequently asked questions
What is FDA product code EZQ?
EZQ is the FDA product code for pouch, colostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EZQ?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EZQ?
Across 6 cleared submissions the average was 119 days from receipt to decision (median 56).
Which companies have the most EZQ clearances?
Convatec, Inc. (2); Convatec (1); Boston Pacific Medical, Inc. (1); Marlen Mfg. & Development Co. (1); Coloplast A/S (1).
Have EZQ devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2022-08-16.
Next steps
- Run an FDA pathway report with predicate devices for product code EZQ
- Run a recall and safety report across every EZQ manufacturer
- Watch product code EZQ 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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