FHA · Class I · 21 CFR 876.5160

FDA Product Code FHA: Clamp, Penile

Leading manufacturers include Cook Urological, Inc., Dacomed Corp. and Laborie Medical Technologies, Ltd..

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 Jul 14, 1998
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
K974040
Timm Research Co.
Gastroenterology & Urology · 263d
Cleared Aug 01, 1997
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
K971992
Uromed Corp.
Gastroenterology & Urology · 64d
Cleared Apr 02, 1997
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
K970308
Mentor Urology, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 10, 1997
CAP-AID (IMPROVED)
K964580
Nebel, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 24, 1996
U-TEX
K955810
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 29d
Cleared Feb 16, 1990
WILLIAMS PENILE ANESTHETIC RETAINER
K896160
Cook Urological, Inc.
Gastroenterology & Urology · 115d
Cleared Feb 08, 1989
DACOMED EXTERNAL MALE CONTINENCE DEVICE
K885323
Dacomed Corp.
Gastroenterology & Urology · 42d
Cleared Feb 03, 1987
COOK-VPI CONTINENCE CUFF
K863227
Cook Urological, Inc.
Gastroenterology & Urology · 166d

About Product Code FHA - Regulatory Context