FAH — Dilator, Urethral, Mechanical Class II

FDA Device Classification

Classification Details

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K933957cook urologicalDILATING URETHRAL SOUNDNovember 17, 1993
K902370boston scientificMODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETERAugust 17, 1990
K902124boston scientificDOWD CATHETERAugust 9, 1990
K831384thomas j. fogarty, m.dCOAXIAL BALLOON URETHRAL DILATORJuly 26, 1983