FAH · Class II · 21 CFR 876.5520

FDA Product Code FAH: Dilator, Urethral, Mechanical

Leading manufacturers include Boston Scientific Corp and Cook Urological, Inc..

4
Total
4
Cleared
89d
Avg days
1983
Since

FDA 510(k) Cleared Dilator, Urethral, Mechanical Devices (Product Code FAH)

4 devices
1–4 of 4
Cleared Nov 17, 1993
DILATING URETHRAL SOUND
K933957
Cook Urological, Inc.
Gastroenterology & Urology · 97d
Cleared Aug 17, 1990
MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER
K902370
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Aug 09, 1990
DOWD CATHETER
K902124
Boston Scientific Corp
Gastroenterology & Urology · 90d

About Product Code FAH - Regulatory Context