FBX — Sound, Urethral, Metal Or Plastic Class I

FDA Device Classification

Classification Details

Product Code
FBX
Device Class
Class I
Regulation Number
876.5520
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K950633candela laserCANDELA URETHRAL/BLADDER SOUNDMarch 6, 1995