FHA · Clamp, Penile
Gastroenterology, Urology · 21 CFR 876.5160 · Class 1
Overview
| Product Code | FHA |
|---|---|
| Device Name | Clamp, Penile |
| Regulation | 21 CFR 876.5160 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.
Classification Rationale
Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Timm Research Co. | Jul 14, 1998 | SESE |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Uromed Corp. | Aug 1, 1997 | SESE |
| K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | Mentor Urology, Inc. | Apr 2, 1997 | SESE |
| K964580 | CAP-AID (IMPROVED) | Nebel, Inc. | Jan 10, 1997 | SESE |
| K955810 | U-TEX | Laborie Medical Technologies, Ltd. | Jan 24, 1996 | SESE |
| K954959 | CAP-AID | Nebl, Inc. | Dec 6, 1995 | SESE |
| K952841 | THE ASSISTANT | Apple Medical Corp. | Aug 18, 1995 | SESE |
| K896160 | WILLIAMS PENILE ANESTHETIC RETAINER | Cook Urological, Inc. | Feb 16, 1990 | SESE |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | Feb 8, 1989 | SESE |
| K863227 | COOK-VPI CONTINENCE CUFF | Cook Urological, Inc. | Feb 3, 1987 | SESE |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | Apr 28, 1978 | SESE |
Top Applicants
- Cook Urological, Inc. — 2 clearances
- Apple Medical Corp. — 1 clearance
- Dacomed Corp. — 1 clearance
- Greenwald Surgical Co., Inc. — 1 clearance
- Laborie Medical Technologies, Ltd. — 1 clearance
