Product code EXE— Gastroenterology, Urology
CONVATEC ABSORBENT BANDAGE
- Classification name
- Protector, Ostomy
- Device class
- Class 1
- Regulation
- 21 CFR 876.5900
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code EXE
FDA has cleared devices under product code EXE between 1977 and 1991, 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
- 1991
- 1977
Top applicants under product code EXE
Adverse events under product code EXE
product code EXE- Injury
- 205
- Malfunction
- 11,191
- Total
- 11,396
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 EXE
Data sourced from openFDA. This site is unofficial and independent of the FDA.