FHA · Class I · 21 CFR 876.5160

FDA Product Code FHA: Clamp, Penile

Leading manufacturers include Cook Urological, Inc..

11
Total
11
Cleared
90d
Avg days
1978
Since

FDA 510(k) Cleared Clamp, Penile Devices (Product Code FHA)

11 devices
1–11 of 11
Cleared Feb 16, 1990
WILLIAMS PENILE ANESTHETIC RETAINER
K896160
Cook Urological, Inc.
Gastroenterology & Urology · 115d
Cleared Feb 03, 1987
COOK-VPI CONTINENCE CUFF
K863227
Cook Urological, Inc.
Gastroenterology & Urology · 166d

About Product Code FHA - Regulatory Context