EZQ
6 FDA 510(k) clearances · Product code
89 daysmedian time to decision
469 days90th percentile
6clearances measured
FDA profile
- Official device name
- Pouch, Colostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2021: 118 · 2022: 94 · 2023: 90 · 2024: 53 · 2025: 104 · 2026: 13
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 |
|---|---|---|
| VITALA CONTINENCE CONTROL DEVICE (K111365) | Convatec, Inc. | 2011-08-19 |
| VITALA CONTINENCE CONTROL DEVICE (K102536) | Convatec, Inc. | 2010-12-01 |
| VITALA CONTINENCE CONTROL DEVICE (K083785) | Convatec | 2010-04-02 |
| 4 SURE TM COLOSTOMY POUCH (K922401) | Boston Pacific Medical, Inc. | 1992-06-10 |
| MARLEN ULTRA ILEOSTOMY POUCH-5000 (K880327) | Marlen Mfg. & Development Co. | 1988-02-19 |
| CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (K863830) | Coloplast A/S | 1986-10-16 |
Track EZQ automatically
Every clearance here is in the API, with alerts when new ones post.