Product code EZP— Gastroenterology, Urology
COLOPLAST OSTOMY ROD, MODEL 12814
- Classification name
- Rod, Colostomy
- Device class
- Class 2
- Regulation
- 21 CFR 876.4270
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code EZP
FDA has cleared devices under product code EZP between 2004 and 2006, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2006
- 2004
Top applicants under product code EZP
Recent clearances under product code EZP
Data sourced from openFDA. This site is unofficial and independent of the FDA.