EZQ — Pouch, Colostomy Class I
FDA product code EZQ covers "Pouch, Colostomy", a Class I medical device regulated under 21 CFR 876.5900. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EZQ
- Device Class
- Class I
- Regulation Number
- 876.5900
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K111365 | convatec | VITALA CONTINENCE CONTROL DEVICE | August 19, 2011 |
| K102536 | convatec | VITALA CONTINENCE CONTROL DEVICE | December 1, 2010 |
| K083785 | convatec | VITALA CONTINENCE CONTROL DEVICE | April 2, 2010 |
| K922401 | boston pacific medical | 4 SURE TM COLOSTOMY POUCH | June 10, 1992 |
| K880327 | marlen mfg. and development | MARLEN ULTRA ILEOSTOMY POUCH-5000 | February 19, 1988 |
| K863830 | coloplast | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM | October 16, 1986 |