FDA product code FHA: Clamp, Penile
FHA is the FDA product code for clamp, penile. It is a Class I device, regulated under 21 CFR 876.5160 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 11 510(k) submissions under FHA, from 10 different applicants. The average 510(k) review took 90 days (median 64). FDA has posted 1 recall for FHA devices.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Penile |
| Device class | Class I |
| Regulation | 21 CFR 876.5160 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FHA clearance
Top FHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Urological, Inc. | 2 | 1990-02-16 |
| Timm Research Co. | 1 | 1998-07-14 |
| Uromed Corp. | 1 | 1997-08-01 |
| Mentor Urology, Inc. | 1 | 1997-04-02 |
| Nebel, Inc. | 1 | 1997-01-10 |
5 more applicants have FHA clearances. See the full list in Caduvo.
Most recent FHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974040 | Timm Research Co. | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | 1998-07-14 | 263 |
| K971992 | Uromed Corp. | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | 1997-08-01 | 64 |
| K970308 | Mentor Urology, Inc. | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | 1997-04-02 | 65 |
| K964580 | Nebel, Inc. | CAP-AID (IMPROVED) | 1997-01-10 | 56 |
| K955810 | Laborie Medical Technologies, Ltd. | U-TEX | 1996-01-24 | 29 |
Recalls for FHA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code FHA?
FHA is the FDA product code for clamp, penile. It is a Class I device, regulated under 21 CFR 876.5160 and reviewed by the Gastroenterology and Urology panel.
What device class is FHA?
Class I, regulation 21 CFR 876.5160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FHA?
Across 11 cleared submissions the average was 90 days from receipt to decision (median 64).
Which companies have the most FHA clearances?
Cook Urological, Inc. (2); Timm Research Co. (1); Uromed Corp. (1); Mentor Urology, Inc. (1); Nebel, Inc. (1).
Have FHA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code FHA
- Run a recall and safety report across every FHA manufacturer
- Watch product code FHA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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