Product code FBX— Gastroenterology, Urology
CANDELA URETHRAL/BLADDER SOUND
- Classification name
- Sound, Urethral, Metal Or Plastic
- Device class
- Class 1
- Regulation
- 21 CFR 876.5520
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code FBX
FDA has cleared device under product code FBX, all in 1995, 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 FBX
Recent clearances under product code FBX
Data sourced from openFDA. This site is unofficial and independent of the FDA.