EZQ · Pouch, Colostomy
Gastroenterology, Urology · 21 CFR 876.5900 · Class 1
Overview
| Product Code | EZQ |
|---|---|
| Device Name | Pouch, Colostomy |
| Regulation | 21 CFR 876.5900 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111365 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | Aug 19, 2011 | SESE |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | Convatec, Inc. | Dec 1, 2010 | SESE |
| K083785 | VITALA CONTINENCE CONTROL DEVICE | Convatec | Apr 2, 2010 | SESE |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Boston Pacific Medical, Inc. | Jun 10, 1992 | SESE |
| K880327 | MARLEN ULTRA ILEOSTOMY POUCH-5000 | Marlen Mfg. & Development Co. | Feb 19, 1988 | SESE |
| K863830 | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM | Coloplast A/S | Oct 16, 1986 | SESE |
Top Applicants
- Convatec, Inc. — 2 clearances
- Boston Pacific Medical, Inc. — 1 clearance
- Coloplast A/S — 1 clearance
- Convatec — 1 clearance
- Marlen Mfg. & Development Co. — 1 clearance
