Product code EZB— Gastroenterology, Urology
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
- Classification name
- Stylet For Catheter, Gastro-Urology
- Device class
- Class 1
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code EZB
FDA has cleared devices under product code EZB between 1987 and 1997, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1997
- 1987
Top applicants under product code EZB
Adverse events under product code EZB
product code EZB- Death
- 4
- Injury
- 141
- Malfunction
- 588
- Total
- 733
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code EZB
Data sourced from openFDA. This site is unofficial and independent of the FDA.