Clamp, Penile
The Penile Clamp is a non-invasive urological device applied externally to the penis to compress the urethra and control urinary incontinence in male patients. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FHA, regulated under 21 CFR 876.5160, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FHA
- Device Class
- FDA class 1
- Regulation Number
- 876.5160
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Jul 14, 1998 | Substantially Equivalent | Timm Research Co. |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Aug 01, 1997 | Substantially Equivalent | Uromed Corp. |
| K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | Apr 02, 1997 | Substantially Equivalent | Mentor Urology, Inc. |
| K964580 | CAP-AID (IMPROVED) | Jan 10, 1997 | Substantially Equivalent | Nebel, Inc. |
| K955810 | U-TEX | Jan 24, 1996 | Substantially Equivalent | Laborie Medical Technologies, Ltd. |
| K954959 | CAP-AID | Dec 06, 1995 | Substantially Equivalent | Nebl, Inc. |
| K952841 | THE ASSISTANT | Aug 18, 1995 | Substantially Equivalent | Apple Medical Corp. |
| K896160 | WILLIAMS PENILE ANESTHETIC RETAINER | Feb 16, 1990 | Substantially Equivalent | Cook Urological, Inc. |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Feb 08, 1989 | Substantially Equivalent | Dacomed Corp. |
| K863227 | COOK-VPI CONTINENCE CUFF | Feb 03, 1987 | Substantially Equivalent | Cook Urological, Inc. |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Apr 28, 1978 | Substantially Equivalent | Greenwald Surgical Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 70 registration numbers. Click on an entry to view related FDA registrations.