meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code FAH — Clearance Directory

Device Class
Class II
21 CFR Citation
876.5520

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K933957 DILATING URETHRAL SOUND Cook Urological, Inc. 1993-11-17 Traditional PDF ↗
K902370 MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER Boston Scientific Corp 1990-08-17 Traditional PDF ↗
K902124 DOWD CATHETER Boston Scientific Corp 1990-08-09 Traditional PDF ↗
K831384 COAXIAL BALLOON URETHRAL DILATOR Thomas J. Fogarty, M.D. 1983-07-26 Traditional PDF ↗

Product code FAH · Class II · Gastroenterology, Urology. Data: openFDA.