FHA
11 FDA 510(k) clearances · Product code
64 daysmedian time to decision
166 days90th percentile
11clearances measured
FDA profile
- Official device name
- Clamp, Penile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5160
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| C3 EXTERNAL MALE BLADDER CONTROL DEVICE (K974040) | Timm Research Co. | 1998-07-14 |
| UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (K971992) | Uromed Corp. | 1997-08-01 |
| MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (K970308) | Mentor Urology, Inc. | 1997-04-02 |
| CAP-AID (IMPROVED) (K964580) | Nebel, Inc. | 1997-01-10 |
| U-TEX (K955810) | Laborie Medical Technologies, Ltd. | 1996-01-24 |
| CAP-AID (K954959) | Nebl, Inc. | 1995-12-06 |
| THE ASSISTANT (K952841) | Apple Medical Corp. | 1995-08-18 |
| WILLIAMS PENILE ANESTHETIC RETAINER (K896160) | Cook Urological, Inc. | 1990-02-16 |
| DACOMED EXTERNAL MALE CONTINENCE DEVICE (K885323) | Dacomed Corp. | 1989-02-08 |
| COOK-VPI CONTINENCE CUFF (K863227) | Cook Urological, Inc. | 1987-02-03 |
| CLAMP, INCONTINENCE, BAUMRUCKER (K780137) | Greenwald Surgical Co., Inc. | 1978-04-28 |
Track FHA automatically
Every clearance here is in the API, with alerts when new ones post.