Panels › Gastroenterology, Urology › Product code FHA · Class 1
Clamp, Penile
Regulation 876.5160
0510(k)s in 12 months (11 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Urological, Inc. | 2 | 0 |
| Aesculap Implant Systems LLC | 0 | 1 |
| Apple Medical Corp. | 1 | 0 |
| Dacomed Corp. | 1 | 0 |
| Greenwald Surgical Co., Inc. | 1 | 0 |
| Laborie Medical Technologies, Ltd. | 1 | 0 |
| Mentor Urology, Inc. | 1 | 0 |
| Nebel, Inc. | 1 | 0 |
| Nebl, Inc. | 1 | 0 |
| Timm Research Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 1998 | K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE Timm Research Co. | FHA |
| Aug 1, 1997 | K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) Uromed Corp. | FHA |
| Apr 2, 1997 | K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE Mentor Urology, Inc. | FHA |
| Jan 10, 1997 | K964580 | CAP-AID (IMPROVED) Nebel, Inc. | FHA |
| Jan 24, 1996 | K955810 | U-TEX Laborie Medical Technologies, Ltd., CA | FHA |
| Dec 6, 1995 | K954959 | CAP-AID Nebl, Inc. | FHA |
| Aug 18, 1995 | K952841 | THE ASSISTANT Apple Medical Corp. | FHA |
| Feb 16, 1990 | K896160 | WILLIAMS PENILE ANESTHETIC RETAINER Cook Urological, Inc. | FHA |
| Feb 8, 1989 | K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE Dacomed Corp. | FHA |
| Feb 3, 1987 | K863227 | COOK-VPI CONTINENCE CUFF Cook Urological, Inc. | FHA |
| Apr 28, 1978 | K780137 | CLAMP, INCONTINENCE, BAUMRUCKER Greenwald Surgical Co., Inc. | FHA |
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