Product code EXN— Gastroenterology, Urology
SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
- Classification name
- Support, Hernia
- Device class
- Class 1
- Regulation
- 21 CFR 876.5970
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code EXN
FDA has cleared device under product code EXN, all in 1990, filed by 1 applicant company. 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.
Top applicants under product code EXN
Recent clearances under product code EXN
Data sourced from openFDA. This site is unofficial and independent of the FDA.