Product code FHA— Gastroenterology, Urology
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
- Classification name
- Clamp, Penile
- Device class
- Class 1
- Regulation
- 21 CFR 876.5160
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code FHA
FDA has cleared devices under product code FHA between 1978 and 1998, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1998
- 1997
- 1996
- 1995
- 1990
- 1989
- 1987
- 1978
Top applicants under product code FHA
Recent clearances under product code FHA
- K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE
- K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
- K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
- K964580 — CAP-AID (IMPROVED)
- K955810 — U-TEX
- K954959 — CAP-AID
- K952841 — THE ASSISTANT
- K896160 — WILLIAMS PENILE ANESTHETIC RETAINER
- K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE
- K863227 — COOK-VPI CONTINENCE CUFF
- K780137 — CLAMP, INCONTINENCE, BAUMRUCKER
Data sourced from openFDA. This site is unofficial and independent of the FDA.